Wireless physiological sensor patches and systems

ABSTRACT

The present invention provides methods, devices, and systems for wireless physiological sensor patches and systems which incorporate these patches. The systems and methods utilize a structure where the processing is distributed asymmetrically on the two or more types of ASIC chips that are designed to work together. The invention also relates to systems comprising two or more ASIC chips designed for use in physiological sensing wherein the ASIC chips are designed to work together to achieve high wireless link reliability/security, low power dissipation, compactness, low cost and support a variety of sensors for sensing various physiological parameters.

CROSS-REFERENCE

This application is a continuation application of U.S. application Ser.No. 14/537,736, filed Nov. 10, 2014, which is a continuation applicationof U.S. application Ser. No. 12/134,151, filed on Jun. 5, 2008, whichclaims the benefit of U.S. Provisional Application Ser. No. 60/968,023,filed Aug. 24, 2007, which applications are incorporated herein byreference in their entirety.

BACKGROUND OF THE INVENTION

Monitoring the health of people has always been important. As thepopulation ages and more people advance in age, health monitoringsystems become more significant to maintaining a healthy lifestyle anddisease management. Remote health monitoring makes it easier and costeffective to monitor the health of vast populations. Wireless systemsare the most desired approach to enable remote health monitoring.Therefore, a variety of wireless health monitoring systems have beenintroduced over the years.

Conventional wireless health monitoring systems are bulky, expensive,have inadequate wireless link reliability and have high powerdissipation which severely limits their applications, particularly tomonitor wide ranging physiological parameters in high volumes for largepopulations. Accordingly, what is desired is a system that addresses theabove-identified issues.

SUMMARY OF THE INVENTION

One aspect of the invention is an asymmetric system comprising: two ormore ASIC chips wherein the chips are designed to work together tomeasure physiological signals, comprising: (a) a patch-ASIC chip adaptedfor incorporation into a physiological signal monitoring patchcomprising a sensor interface, a processor coupled to the sensorinterface, a memory element coupled to the processor, a radio coupled tothe memory element that transmits data to a base-ASIC chip, and powermanagement circuits that coordinate power usage on the chip; and (b) thebase-ASIC chip, comprising a processor that processes sensor data, amemory element coupled to the processor, a radio coupled to the memoryelement that communicates instructions to the patch-ASIC chip, powermanagement circuits for coordinating power usage on the chip, and a hostinterface through which the base-ASIC chip communicates with a hostdevice;

In some embodiments the base-ASIC chip has more processing resourcesthan the patch-ASIC chip.

In some embodiments the base-ASIC has a higher silicon area than thepatch-ASIC chip. In some embodiments the ratio of silicon area of thebase-ASIC chip to the patch-ASIC chip is at least about 2:1. In someembodiments the ratio of silicon area of the base-ASIC chip to thepatch-ASIC chip is at least about 4:1.

In some embodiments the patch-ASIC chip comprises low-complexitytransmitters and low complexity receivers, and the base-ASIC chipcomprises high-complexity transmitters and high complexity receivers.

In some embodiments the patch-ASIC chip comprises a UWB transmitter anda narrowband receiver, and the base-ASIC chip comprises a narrow bandtransmitter and a UWB receiver.

In some embodiments the patch-ASIC chip comprises a turbo encoder, andthe base-ASIC chip comprises a turbo-decoder. In some embodiments thepatch-ASIC chip communicates through a single antenna, and the base-ASICchip communicates through multiple antennas. In some embodiments thebase-ASIC chip further comprises smart antenna processing. In someembodiments the base-ASIC chip, comprises processors for analyzing theradio environment. In some embodiments the system comprises a base-ASICchip and multiple patch-ASIC chips.

One aspect of the invention is a method comprising: monitoring aphysiological condition using two or more ASIC chips and a host devicewherein the chips are designed to work together to measure physiologicalsignals comprising: (a) receiving signals from a sensor at a patch-ASICchip that is incorporated into a physiological signal monitoring patch,the patch-ASIC chip comprising a sensor interface coupled to the sensor,a processor coupled to the sensor interface, a memory element coupled tothe processor, a radio coupled to the memory element; (b) transmittingdata signals from the radio on the patch-ASIC chip through an antennaincorporated into the patch; (c) receiving the data signals at abase-ASIC chip comprising an antenna that sends the signals to aprocessor that processes data signals, a memory element coupled to theprocessor, a radio coupled to the memory element, and a host interfacethrough which the base-ASIC chip communicates with a host device; and(d) transmitting instructions wirelessly from the base-ASIC chip to thepatch-ASIC chip; wherein the base-ASIC chip consumes more power than thepatch-ASIC chip.

In some embodiments the ratio of power consumed by the base-ASIC chip tothe power consumed by the patch-ASIC chip measured during continual datatransmission is 2:1. In some embodiments the ratio of power consumed bythe base-ASIC chip to the power consumed by the patch-ASIC chip measuredduring continual data transmission is 4:1.

One aspect of the invention is a system comprising two or more ASICchips wherein the chips are designed to work together to measurephysiological signals, comprising: (a) a patch-ASIC chip adapted forincorporation into a physiological signal monitoring patch comprising asensor interface, a processor coupled to the sensor interface, a memoryelement coupled to the processor, a radio coupled to the memory elementthat transmits data to a base-ASIC chip, and power management circuitsthat coordinate power on the chip; and (b) the base-ASIC chip comprisinga processor that processes sensor data, a memory element coupled to theprocessor, a radio coupled to the memory element that that transmitsinstructions to the patch-ASIC chip, power management circuits forcoordinating power on the chip, and a host interface through which thebase-ASIC chip communicates with a host device.

In some embodiments the base-ASIC chip is incorporated into a μ-Base andthe patch-ASIC chip is incorporated into a μ-Patch, wherein each of theμ-Base and the μ-Patch comprise a printed circuit board and an antennaattached to the printed circuit board for transmitting radio signals. Insome embodiments the base-ASIC chip acts as a master device tocoordinate a function of the μ-Patch. In some embodiments a functioncoordinated by the base-ASIC chip is initialization and link set up,power management, data packet routing, type of transmission radio, radiotransmit-power, radio receive-sensitivity, patch operational integrity,audio tone generation, display activation, or a combination thereof. Insome embodiments the base-ASIC chip can coordinate the bias of the RFcircuitry on the patch-ASIC chip to coordinate energy usage on thepatch.

In some embodiments the base-ASIC chip is incorporated into the hostdevice; wherein the host device comprises a stationary, portable, ormobile device or a stationary, portable, or mobile medical instrument.In some embodiments the base-ASIC chip is incorporated into an adapterwhich plugs into the host device; wherein the host device comprises astationary, portable or mobile device or a stationary, portable, ormobile medical instrument. In some embodiments the adapter comprisingthe base-ASIC chip plugs into a medical instrument through a serialinterface connection. In some embodiments the adapter providesphysiological information from wireless sensors to a stationary,portable, or mobile medical instrument that was designed for receivingphysiological information from wired sensors, wherein the adapter allowsthe medical instrument to receive substantially equivalent informationfrom the wireless sensors. In some embodiments the adapter allows amedical instrument which is designed to be connected to sensors by wiresto be compatible with sensors that transmit wirelessly. In someembodiments the base-ASIC chip is incorporated into a cell phone.

In some embodiments the patch-ASIC chip and the base-ASIC chip are eachpart of an ASIC superset chip, wherein the functionality of both thepatch-ASIC chip and the base-ASIC chip are contained on the ASICsuperset chip, and wherein un-used portions of the superset chip areturned off on the patch-ASIC chip or the base-ASIC chip.

In some embodiments the two or more ASIC chips can send and/or receiveboth ultrawide band (UWB) radio and narrowband radio signals. In someembodiments the base-ASIC chip can switch the transmission mode of thepatch-ASIC chip between UWB and narrowband radio. In some embodimentsthe patch-ASIC chip comprises an encoding scheme for encoding datatransmission and the base-ASIC chip comprises a decoding scheme fordecoding data transmission from the μ-Patch. In some embodiments thesystem provides security by an encryption scheme using shared keys,wherein the device comprising the base-ASIC chip wirelessly exchangesthe shared keys with the patch. In some embodiments the ASIC chips canavoid or minimize interference by pseudo-random hopping of carrierfrequencies, or by data modulation with pseudo-random code sequences. Insome embodiments the system provides reliability by forward-errorcorrection, packet-retransmission by automatic repeat request (ARQ),and/or smart antenna techniques.

In some embodiments the μ-Patch comprises one antenna and the μ-Basecomprises 2 or more antennas. In some embodiments the μ-Patch performscompression of the radio signal and the μ-Base performs decompression ofthe radio signal.

In some embodiments the μ-Base further comprise a power amplifierexternal to the base-ASIC chip for amplifying sensor data signal. Insome embodiments the μ-Base can transmit at 5 times higher power thanthe μ-Patch.

In some embodiments the system comprises one base-ASIC chip and multiplepatch-ASIC chips.

In some embodiments the μ-Patch uses on average less than about 6 mW ofpower. In some embodiments the patch-ASIC chip can transmit more thanabout 1 KB of data per day to the base-ASIC chip. In some embodimentsthe patch-ASIC chip can transmit more than about 1 KB of data per day ata range of up to 30 m to the base-ASIC chip.

One aspect of the invention is a system comprising three or more ASICchips wherein the chips are designed to work together to measurephysiological signals, comprising: (a) a patch-ASIC chip adapted forincorporation into a physiological signal monitoring patch comprising asensor interface, a processor coupled to the sensor interface, a memoryelement coupled to the processor, a radio coupled to the memory elementthat transmits sensor data to a base-ASIC chip and/or a gate-ASIC chip,and power management circuits that coordinate power on the chip; (b) thegate-ASIC chip comprising a processor that processes sensor data, amemory element coupled to the processor, a radio coupled to theprocessor that communicates with the patch-ASIC chip and the base-ASICchip, and power management circuits that coordinate power on the chip;and (c) the base-ASIC chip comprising a processor that processes sensordata, a memory element coupled to the processor, a radio coupled to thememory element that that transmits instructions to the patch-ASIC chipand/or the gate-ASIC chip, power management circuits that coordinatepower on the chip, and a host interface through which the base-ASIC chipcommunicates with a host device.

In some embodiments the base-ASIC chip is incorporated into a μ-Base,the patch-ASIC chip is incorporated into a μ-Patch, and the gate-ASICchip is incorporated into a μ-Gate; wherein each of the μ-Base, μ-Patch,and μ-Gate comprise a printed circuit board and an antenna attached tothe printed circuit board for transmitting radio signals.

In some embodiments the gate-ASIC chip further comprises a sensorinterface for receiving signals from sensors, wherein the μ-Gate isincorporated into a patch. In some embodiments the μ-Patch onlytransmits UWB, and the μ-Gate has both a UWB and a narrowband radio. Insome embodiments the base-ASIC chip acts as a master device tocoordinate a function of the μ-Patch or the μ-Gate or both the μ-Patchand the μ-Gate. In some embodiments the base-ASIC chip can switch thetransmission mode of the μ-Patch and/or the μ-Gate between UWB andnarrowband radio.

In some embodiments the base-ASIC chip is incorporated into the hostdevice; wherein the host device comprises a stationary, portable, ormobile device or a stationary, portable, or mobile medical instrument.In some embodiments the base-ASIC chip is incorporated into an adapterwhich plugs into the host device; wherein the host device comprises astationary, portable or mobile device or a stationary, portable, ormobile medical instrument.

In some embodiments the gate-ASIC chip communicates wirelessly with boththe patch-ASIC chip and the base-ASIC chip.

In some embodiments the patch-ASIC chip and the gate-ASIC chip are eachmembers of an ASIC superset; and wherein the unused portions on thepatch-ASIC chip and/or the base-ASIC are turned off. In some embodimentsthe patch-ASIC chip, the gate-ASIC chip and the base-ASIC chip are eachpart of an ASIC superset chip, wherein the functionality of two or moreof the patch-ASIC chip, the gate-ASIC chip and the base-ASIC chip arecontained on the ASIC superset chip, and wherein un-used portions of thesuperset chip are turned off on the patch-ASIC chip, the gate-ASIC chip,or the base-ASIC chip. In some embodiments the adapter comprising thebase-ASIC chip plugs into a medical instrument through a serialinterface connection. In some embodiments adapter provides physiologicalinformation from wireless sensors to a stationary, portable, or mobilemedical instrument that was designed for receiving physiologicalinformation from wired sensors, wherein the adapter allows the medicalinstrument to receive substantially equivalent information from thewireless sensors. In some embodiments the adapter allows a medicalinstrument which is designed to be connected to sensors by wires to becompatible with sensors that transmit wirelessly.

One aspect of the invention is a patch for measuring a physiologicalstate comprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the area of the patch multiplied by the thicknessof the patch is less than about 30 cm³; and wherein the patch canwirelessly transmit physiological data for at least about 2 days whilemonitoring a physiological signal from the patient without changing orrecharging the battery.

In some embodiments the monitoring of the physiological signal issampled substantially continuously. In some embodiments the signal issampled substantially continuously at greater than 200 Hz. In someembodiments the patch can wirelessly transmit physiological data for atleast about 4 days. In some embodiments the battery provides a charge ofabout 250 mA-hours or less.

In some embodiments the patch buffers data obtained from monitoring aphysiological signal then transmits the data in bursts. In someembodiments the patch uses on average less than about 10 mW of power.

In some embodiments the patch can transmit more than about 1 KB ofsensor data per day at a range of up to 30 m. In some embodiments thepower management circuits coordinate duty cycle with clock-gating withprotocol-level sleep modes. In some embodiments the patch can measuresignals in continuous, episodic, and/or periodic modes.

In some embodiments the patch also comprises a sensor. In someembodiments the sensor comprises electrodes and senses electricalsignals. In some embodiments the sensor measures EEG, EMG, or ECGsignals or combinations thereof.

In some embodiments the ASIC chip can send and/or receive bothultra-wideband (UWB) and narrowband radio signals.

In some embodiments the patch comprises disposable and reusable parts.In some embodiments a sensor and/or the battery are disposable, andsubstantially all of the electronics are reusable. In some embodimentsthe patch is disposable.

In some embodiments the sensor is separate from the patch andelectrically connected to the patch.

In some embodiments the sensor measures ECG, EEG, EMG, SpO2, tissueimpedance, heart rate, accelerometer, blood glucose, PT-INR, respirationrate and airflow volume, body tissue state, bone state, pressure,physical movement, body fluid density, patient physical location, oraudible body sounds, or a combination thereof. In some embodiments thepatch can generate stimulus signals that are detected by sensorsconnected to or incorporated into the patch or connected to orincorporated into another patch. In some embodiments the stimulussignals are electrical, ultrasound, or radio wave signals. In someembodiments the electrical signals are used to measure skin or bodyimpedance.

In some embodiments the patch comprises an alert which is an audiosignal generator or a visual display. In some embodiments the batterycan be re-charged via electromagnetic induction.

One aspect of the invention is a patch for measuring a physiologicalstate comprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the patch is a cardiac patch that can measure allof ECG, SpO2, tissue impedance, accelerometer, and PT-INR signals.

One aspect of the invention is a patch for measuring a physiologicalstate comprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the patch is a neurological patch for measuringsleep apnea that can measure all of EEG, EMG, SpO2, heart rate,respiration rate and airflow volume, and pressure signals.

One aspect of the invention is a patch for measuring a physiologicalstate comprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the patch is an endocrinological patch formeasuring diabetes or wounds that can measure all of ECG, blood glucose,and UWB radar signals.

One aspect of the invention is a patch for measuring a physiologicalstate comprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the patch is fitness and wellness patch that canmeasure all of ECG, heart rate, accelerometer, and pressure signals.

One aspect of the invention is a method comprising monitoring aphysiological condition using two or more ASIC chips and a host devicewherein the chips are designed to work together to measure physiologicalsignals comprising: (a) receiving signals from a sensor at a patch-ASICchip that is incorporated into a physiological signal monitoring patch,the patch-ASIC chip comprising a sensor interface coupled to the sensor,a processor coupled to the sensor interface, a memory element coupled tothe processor, a radio coupled to the memory element; (b) managing thepower dissipation on the patch-ASIC chip with power management circuitson the patch-ASIC chip; (c) transmitting data signals from the radio onthe patch-ASIC chip through an antenna incorporated into the patch; (d)receiving the data signals at a base-ASIC chip comprising a processorthat processes data signals, a memory element coupled to the processor,a radio coupled to the memory element, power management circuits thatcoordinate power dissipation on the base-ASIC chip, and a host interfacethrough which the base-ASIC chip communicates with a host device; and(e) sending instructions wirelessly from the base-ASIC chip to thepatch-ASIC chip such that the base-ASIC chip coordinates a function ofthe physiological signal monitoring patch.

In some embodiments a function coordinated by the base-ASIC chip isinitialization and link set up, power management, data packet routing,type of transmission radio, radio transmit-power, radioreceive-sensitivity, patch operational integrity, audio signalgeneration, display activation, or a combination thereof. In someembodiments the ASIC chips function on a packet-data protocol and thebase-ASIC chip coordinates data packet routing. In some embodiments thebase-ASIC chip keeps track of the quality of the wireless links betweenASIC chips and sends commands to the patch-ASIC chip and/or gate-ASICchips to instruct the chips to switch between UWB and narrowband radioor to raise or lower transmit power in order to lower power consumptionor to enhance communication quality. In some embodiments the patch-ASICchip is authenticated by bringing the physiological monitoring patch inproximity of the device comprising the base-ASIC chip.

In some embodiments the authentication is provided by an encryptionscheme using shared keys, wherein the device comprising the base-ASICchip wirelessly exchanges the shared keys with the patch. In someembodiments the encryption scheme is an Advanced Encryption Standard(AES) scheme. In some embodiments a user is alerted with an audio and/ora visual signal. In some embodiments the audio and/or visual signal isgenerated on the patch. In some embodiments the audio and/or visualsignal is generated on a device to which the base-ASIC chip isconnected.

In some embodiments the method is used to manage a patient disease. Insome embodiments the patient disease is arrhythmia, heart failure,coronary heart disease, diabetes, sleep apnea, seizures, asthma, COPD,pregnancy complications, and wound state or combinations thereof. Insome embodiments the method is used to manage a condition related to thestate of wellness and fitness of a person. In some embodiments thecondition being managed is weight loss, obesity, heart rate, cardiacperformance, dehydration rate, blood glucose, physical activity orcalorie intake, or combinations thereof.

A method comprising monitoring a physiological condition using three ormore ASIC chips wherein the chips are designed to work together tomeasure physiological signals, comprising: (a) receiving physiologicalsignals from sensors at a patch-ASIC chip incorporated into aphysiological signal monitoring patch, the patch-ASIC chip comprising asensor interface, a processor coupled to the sensor interface, a memoryelement coupled to the processor, a radio coupled to the memory element;(b) managing power dissipation on the patch-ASIC chip with powermanagement circuits on the patch-ASIC chip; (c) transmitting data to abase-ASIC and/or a gate-ASIC chip through an antenna in the patch; (d)receiving the data sent from the patch-ASIC chip at the gate-ASIC chip,the gate-ASIC chip comprising a processor that processes sensor data, amemory element coupled to the processor, a radio coupled to theprocessor that communicates with the patch-ASIC chip and the base-ASICchip, and power management circuits for coordinating power dissipationon the gate-ASIC chip; (e) coordinating a function on the patch-ASICchip and/or gate-ASIC chip by sending instructions from a base-ASIC chipto the patch-ASIC chip and/or the gate-ASIC chip, wherein the base-ASICchip comprises a processor that processes sensor data, a memory elementcoupled to the processor, a radio coupled to the memory element, powermanagement circuits for coordinating power dissipation on the base-ASICchip; and (f) sending data from the base-ASIC chip to a host devicethrough a host interface.

In some embodiments the base-ASIC chip is incorporated into a μ-Base,the patch-ASIC chip is incorporated into a μ-Patch, and the gate-ASICchip is incorporated into a μ-Gate; wherein each of the μ-Base, μ-Patch,and μ-Gate comprise a printed circuit board and an antenna attached tothe printed circuit board for transmitting and receiving radio signals.

In some embodiments the gate-ASIC chip further comprises a sensorinterface for receiving signals from sensors, wherein the gate-ASIC isincorporated into a patch.

In some embodiments the μ-Patch only transmits UWB, and the μ-Gatecomprises both UWB and narrowband radios.

In some embodiments the base-ASIC chip acts as a master device tocoordinate a function of the μ-Patch or the μ-Gate or both the μ-Patchand the μ-Gate. In some embodiments the base-ASIC chip keeps track ofthe quality of the wireless links between ASIC chips and sends commandsto the patch-ASIC chip and/or gate-ASIC chips to instruct the chips toswitch between UWB and narrowband radio or to raise or lower transmitpower in order to lower power consumption or to enhance communicationquality. In some embodiments the base-ASIC chip is incorporated into thehost device; wherein the host device comprises a stationary, portable,or mobile device or a stationary, portable, or mobile medicalinstrument.

In some embodiments the base-ASIC chip is incorporated into an adapterwhich plugs into the host device; wherein the host device comprises astationary, portable or mobile device or a stationary, portable, ormobile medical instrument. In some embodiments the gate-ASIC chipcommunicates wirelessly with both the patch-ASIC chip and the base-ASICchip. In some embodiments the patch-ASIC chip and the gate-ASIC chip areeach members of an ASIC superset; and wherein an unused function on thepatch-ASIC chip is turned off

In some embodiments the patch-ASIC chip, the gate-ASIC chip and thebase-ASIC chip are each part of an ASIC superset chip, wherein thefunctionality of two or more of the patch-ASIC chip, the gate-ASIC chipand the base-ASIC chip are contained on the ASIC superset chip, andwherein un-used portions of the superset chip are turned off on thepatch-ASIC chip, the gate-ASIC chip, or the base-ASIC chip.

In some embodiments the base-ASIC chip is incorporated into an adapterwhich plugs into the host device; wherein the host device comprises astationary, portable or mobile device or a stationary, portable, ormobile medical instrument. In some embodiments the adapter comprisingthe base-ASIC chip plugs into a medical instrument through a serialinterface connection. In some embodiments the adapter providesphysiological information from wireless sensors to a stationary,portable, or mobile medical instrument that was designed for receivingphysiological information from wired sensors, wherein the adapter allowsthe medical instrument to receive substantially equivalent informationfrom the wireless sensors. In some embodiments the adapter allows amedical instrument which is designed to be connected to sensors by wiresto be compatible with sensors that transmit wirelessly.

One aspect of the invention is a method comprising receivingphysiological signals from sensors at a patch wherein the patchcomprises a battery and an antenna each coupled to an integrated circuitcomprising a sensor interface that receives the physiological signalsfrom the sensor, a processor coupled to the sensor interface thatreceives signals from the sensor interface and processes the signals, amemory element coupled to the processor that receives and storessignals, and a radio coupled to the memory element that sends signalsreceived from the memory element to an antenna, wherein power managementcircuits coordinate power dissipation on the chip; wherein the area ofthe patch multiplied by the thickness of the patch is less than about 30cm³; and wherein the patch can wirelessly transmit physiological datafor at least about 2 days while monitoring a physiological signal fromthe patient without changing or recharging the battery. In someembodiments the monitoring of the physiological signal is sampledsubstantially continuously. In some embodiments the signal is sampledsubstantially continuously at greater than 200 Hz. In some embodimentsmethod can wirelessly transmit physiological data for at least about 4days. In some embodiments the battery provides a charge of about 250mA-hours or less. In some embodiments the patch buffers data obtainedfrom monitoring a physiological signal then transmits the data inbursts. In some embodiments the patch uses on average less than about 10mW of power. In some embodiments the patch can transmit more than about1 KB of sensor data per day at a range of up to 30 m. In someembodiments the power management circuits coordinate duty cycle withclock-gating with protocol-level sleep modes. In some embodiments thepatch can measure signals in continuous, episodic, and/or periodicmodes.

In some embodiments the patch also comprises the sensor. In someembodiments the sensor comprises electrodes and senses electricalsignals. In some embodiments the sensor measures EEG, EMG and ECGsignals or combinations thereof. In some embodiments the ASIC chip cansend and/or receive both ultra-wideband (UWB) and narrowband radiosignals.

In some embodiments the patch comprises disposable and reusable parts.In some embodiments a sensor and/or the battery are disposable, andsubstantially all of the electronics are reusable. In some embodimentsthe patch is disposable.

In some embodiments the sensor is separate from the patch andelectrically connected to the patch. In some embodiments the sensormeasures ECG, EEG, EMG, SpO2, tissue impedance, heart rate,accelerometer, blood glucose, PT-INR, respiration rate and airflowvolume, body state, bone state, pressure, physical movement, body fluiddensity, patient physical location, or audible body sounds, or acombination thereof. In some embodiments the method can generatestimulus signals that are detected by sensors connected to orincorporated into the patch or connected to or incorporated into anotherpatch. In some embodiments the stimulus signals are electrical,ultrasound, or radio wave signals. In some embodiments the electricalsignals are used to measure skin or body impedance. In some embodimentsthe patch comprises an alert which is an audio signal generator or avisual display. In some embodiments the battery can be re-chargedmagnetically.

In some embodiments the patch is a cardiac patch that can measure all ofECG, SpO2, tissue impedance, accelerometer, and PT-INR signals. In someembodiments the patch is a neurological patch for measuring sleep apneathat can measure all of EEG, EMG, SpO2, heart rate, respiration rate andairflow volume, and pressure signals. In some embodiments the patch isan endocrinological patch for measuring diabetes or wounds that canmeasure all of ECG, blood glucose, and UWB radar signals. In someembodiments the patch is fitness and wellness patch that can measure allof ECG, heart rate, accelerometer, and pressure signals.

One aspect of the invention is a method for unsupervised placement of aphysiological patch comprising: (a) placing the patch that can receivewireless signals from a base device, wherein the patch comprises avisual marker to help the user orient the patch on the patient's body;(b) initializing the patch with a base device by automatic verificationof proper placement of the patch; and (c) indicating the proper orimproper placement of the patch to the user with an audio or visualindication.

One aspect of the invention is a business method comprising: a)manufacturing both a patch-ASIC chip and a base-ASIC chip designed towork together to wirelessly communicate physiological data, wherein eachchip each comprises a processor, memory storage, a wireless radio, andcircuits for power management, wherein the chips are designed to be usedwith a plurality sensor types; and (b) selling and/or licensing thepatch-ASIC chip and base-ASIC chip to multiple customers forincorporation into physiological sensing systems.

The business method of claim 141 wherein the plurality of sensor typesinclude sensors that measure all of ECG, EEG, EMG, SpO2, tissueimpedance, heart rate, and accelerometer signals.

The business method of claim 141 further comprising a gate-ASIC chipdesigned to work together with the patch-ASIC chip and the base-ASICchip, to wirelessly communicate physiological data, wherein each chipeach comprises a processor, memory storage, a wireless radio, andcircuits for power management, wherein the chips are designed to be usedwith a plurality sensor types.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A is a block diagram of a first embodiment of a generalarchitecture of wireless health monitoring system in accordance with thepresent invention.

FIG. 1B is a block diagram of a second embodiment of a generalarchitecture of a wireless health monitoring system in accordance withthe present invention.

FIG. 2 illustrates examples of various sensors that can be included in adistributed sensor network.

FIG. 3 illustrates a block diagram of a wireless patch in accordancewith the present invention.

FIG. 3A illustrates a block diagram of another embodiment of a patch inaccordance with the present invention.

FIG. 4 illustrates a block diagram of a medical signal processor(μ-Base) in accordance with the present invention.

FIG. 4A illustrates a block diagram of another embodiment of a medicalsignal processor (μ-Base) in accordance with the present invention.

FIG. 5 is a block diagram of a cardiac care product in accordance withthe present invention.

FIG. 6 is a block diagram of an implementation of a mobile deviceutilized with the cardiac care product of FIG. 5.

FIG. 7 illustrates a system of the present invention includingμ-Patches, μ-Gates, and a μ-Base incorporated into a host device.

DETAILED DESCRIPTION OF THE INVENTION

The current invention relates to patches, integrated circuits (chips),systems and methods for a wireless medical signal processing system forhealth monitoring which can achieve high wireless linkreliability/security, low power dissipation, compactness, low cost andsupports a variety of sensors for various physiological parameters. Oneaspect of the invention is a wireless system for monitoringphysiological conditions comprising two or more ASIC chips that aredesigned to work together to optimize the performance of a wirelessmonitoring system. One of the ASIC chips is designed to be incorporatedinto a patch attached to a patient (the patch-ASIC chip), and one of theASIC chips is incorporated into a mobile or stationary device (thebase-ASIC chip). Typically, the base-ASIC chip will be incorporated intoa device that will tend to be in the vicinity of the patient. The two ormore ASIC chips are designed in order to improve the performance of thesystem by distributing the different aspects of functionality betweenthe different chip types. Thus the ASIC chips are designed to functionin an asymmetric manner in which the base-ASIC will perform more of theprocessing intensive tasks. In some cases, the base-ASIC will performall or a majority of functions of a particular type, while thepatch-ASIC chip may perform all or a majority of functions of anothertype. This asymmetric design of the sets of ASIC chips can improve theperformance of the physiological monitoring system resulting in bettermanagement of power, lower cost, and higher reliability.

In one aspect, the base-ASIC chip is designed to coordinate some of thefunctions on the patch through the patch-ASIC chip. In many cases, thebase-ASIC is incorporated such that it has access to much more power andenergy than does the patch-ASIC chip. Thus, the system of the currentinvention comprises an asymmetric system in which the base-ASIC chiptakes on more power and processor intensive functions. This approach canresult in lower power dissipation at the patch, which can in turn resultin a physiological monitoring system in which the patch can collect andtransmit data for days or weeks without recharging or replacingbatteries. In addition, the base-ASIC can control the flow of data in anetwork of patches in order to improve the management of data relatingto signals, increasing the amount and quality of physiologicalinformation. For example, the base-ASIC chip can supervise and controlthe functions of the patch-ASIC chip, for example by controlling dutycycle, transmission mode, transmission rate, and transmission timing.The base-ASIC and patch-ASIC chips can be designed such that thecoding/decoding functions are asymmetric. For example, the patch-ASICcan be build to carry out Turbo encoding, which is relatively simple,and the base-ASIC can be designed to carry out Turbo-decoding which ismore complex, and requires more processing power and therefore uses moreenergy. Another aspect of asymmetric design of the ASIC chips involvesproviding a complex antenna scheme such as the use of multiple antennaswith smart antenna processing on the base-ASIC, and the use of a singleantenna with simple processing on the gate-ASIC. Another aspect of theasymmetric design is the use of different radio scheme capability on thegate-ASIC and base-ASIC chips. For example, low-complexity transmitters(e.g. UWB) and low-complexity receivers (e.g. Narrow-band) are employedon the on patch-ASIC; and high-complexity transmitters (e.g. Narrowband) and high-complexity receivers (e.g. UWB) are employed on thebase-ASIC. Another aspect of the asymmetry has to do with distributingthe functions of analyzing and controlling the radio channel. Here, thebase-ASIC has all the processors for analyzing the radio environment andsending instructions to patch-ASIC to use a particular radio scheme; andthe patch-ASIC has simple circuits to just follow the instructionscoming from Base ASIC.

In some embodiments two or more of these distributed aspects are coupledtogether, for example, where the base-ASIC and patch-ASIC are designedto work together such that the base-ASIC has processors forturbo-decoding, multiple antennas and smart antenna processingcapability, and high-complexity transmitters (e.g. Narrow band) andhigh-complexity receivers (e.g. UWB); and the patch-ASIC has processorsfor Turbo decoding, the capability of receiving signals from a singleantenna, and has low-complexity transmitters (e.g. UWB) andlow-complexity receivers.

One aspect of the asymmetric distributed processing of the presentinvention is a patch-ASIC chip and a base-ASIC chip designed to worktogether in which the area of the base-ASIC chip is higher than that ofthe patch-ASIC chip. This difference in area results, for example, fromthe fact that the base-ASIC chip takes on the more processor intensiveoperations in carrying out the monitoring of a patient's physicalcondition. In some embodiments, the area of the base-ASIC chip is morethan 2 times the area of the patch-ASIC chip. In some embodiments, thearea of the base-ASIC chip is more than 4 times the area of thepatch-ASIC chip.

One aspect of the asymmetric distributed processing of the presentinvention is a method wherein a patch-ASIC chip and a base-ASIC chipdesigned to work together and in which the power consumed by thebase-ASIC chip is higher than the power consumed by the patch-ASIC chip.In some embodiments the power consumed by the base-ASIC is 2 or moretimes the power consumed by the patch-ASIC chip. In some embodiments thepower consumed by the base-ASIC is 4 or more times the power consumed bythe patch-ASIC chip. The power consumption (power dissipation) of thechips can be measured, for example during continual data transmission.

In some embodiments of the system the base-ASIC is incorporated into aμ-Base (or medical signal processor (MSP)) comprising a printed circuitboard and an antenna attached to the printed circuit board. In someembodiments of the system the patch-ASIC is incorporated into a μ-Patchcomprising a printed circuit board and an antenna attached to theprinted circuit board. In some embodiments, the antenna is a PCBantenna.

One aspect of the invention is an asymmetric system for wirelessmonitoring wherein the two ASIC chips are designed such that thebase-ASIC chip carries out the more power and processor intensivefunctions of the system. For example, in some embodiments, the base-ASICchip carries out smart antenna schemes, which can be processor and powerintensive, which allows the μ-Base reliably detect weaker signals, thusallowing the μ-Patch to transmit at lower power, saving energy on thepatch. Analogously, in some embodiments, the μ-Base will have multipleantennas, e.g. 4 antennas, for implementation of the smart antennaschemes. In some embodiments, in order to provide reliability for thesystem while using low power at the patch, the base-ASIC chip carriesout decoding functions which are processor and power intensive, whilethe patch-ASIC chip carries out encoding which is less processor andpower intensive. This asymmetric scheme is facilitated in part becauseof the data transfer asymmetry of the system in many embodiments, inwhich the patch is transmitting much more data to the μ-Base than theμ-Base is transmitting to the patch because the patch is generallytransferring physiological sensor data to the μ-Base, and the μ-Base issending back mainly instructions to control functions on the patch-ASICchip and the patch.

The base-ASIC chip can be connected to or built into a stationary,portable, or mobile device. In some embodiments, the base-ASIC chip isconnected to or built into a cellular phone, pager, i-Pod™, PDA, orother mobile device that would tend to be carried by or be near thepatient. In some embodiments, the base-ASIC chip is connected to orbuilt into a laptop, notebook, palm-top, or desk-top computer. In someembodiments, the base-ASIC chip is connected to or built into a medicalinstrument for monitoring physiological signals related to healthconditions such as ECG, EEG, EMG, SpO₂, tissue impedance, heart rate,accelerometer, blood glucose, PT-INR, respiration rate and airflowvolume, UWB radar, pressure, physical movement, body fluid density,patient physical location, or audible body sounds. The medicalinstrument can be stationary, desk-top, portable, or mobile.

In some embodiments, the base-ASIC chip is incorporated into an adaptorthat is connected to a medical instrument such as a medical monitor,wherein the adaptor communicates wirelessly with one or more patcheshaving a patch-ASIC chip. The adaptor receives the physiological signalfrom one or more patches, translates the physiological signal to asignal that is compatible with the medical monitor, and sends thetranslated signal to the medical monitor. In some embodiments, theadaptor is connected to the medical monitor with the same connector towhich the medical monitor connects to wired sensors. In someembodiments, the adaptor is connected to a medical monitor that wasdesigned to work with wired sensors through a different connection thanused for the wired sensors. For instance the adaptor may connect to themedical device through a USB or SDIO port. In these embodiments, theadaptor comprising the base-ASIC chip allows medical monitors designedfor use with wired sensors to be used with wireless sensors with minimalor with no modification to the medical monitor.

In some embodiments, in addition to the patch-ASIC chip and thebase-ASIC chip, the system further includes a gate-ASIC chipincorporated into a gate device. In some cases the gate-ASIC chip isattached to a μ-Gate, comprising a printed circuit board with an antennaattached to the printed circuit board. In some embodiments, the gatedevice acts as an intermediary (gateway), for instance, controllingcommunication between the base-ASIC chip and the patch-ASIC chip. Thegate device is useful, for instance in circumstances where the patientwearing the wireless patch may be moved a distance away from thebase-ASIC chip for relatively long time periods. In these situations,the gate-device, which will typically be small enough to, for example,be comfortably carried in a pocket, can communicate with the patch-ASICchip while the patch-ASIC chip is out of communication range of thebase-ASIC chip, continuing to monitor and/or control the functions ofthe patch, and collect and store data sent by the patch, and be able toforward that data to the μ-Base wirelessly. In general, in systems whereone or more gate devices are present, patch devices communicate to theμ-Base via the gate device(s). This helps reduce the power consumptionof the patch devices as they can transmit at lower power to communicatewith the gate device(s) which are in closer proximity than the μ-Baseitself.

In some embodiments the gate devices can be incorporated into patches.In these cases, the gate device can perform its gateway function, andcan also perform as a patch by being connected (wired) to sensors andreceiving physiological signals. For example, one system of the presentinvention has multiple patches, each patch comprising a patch-ASIC chip;and a gate device comprising a gate-ASIC chip incorporated into a patchon a patient. The gate device can communicate with the multiple patcheson the patient, and the gate device can act as an intermediary betweenthe patches comprising the patch-ASIC and a μ-Base comprising abase-ASIC. In one embodiment of this system, the patch-ASICs communicateonly by UWB, while the gate-ASIC can communicate with the base-ASIC byeither UWB or narrowband. This system allows the patches withpatch-ASICs to operate at low power and to have low energy usage bytransmitting only in UWB. In this embodiment, the gate-device may have alarger battery than the patches comprising the patch-ASIC chips. In someembodiments, the patch-ASIC chips used in this scenario can be madeinexpensively due to the fact that the chips do not have multipleradios. In other embodiments, the patch-ASIC chip and the gate-ASIC chipused in this scenario are made as part of an ASIC superset, where thenarrowband radio can be turned off on the patch-ASIC chip. The use of anASIC superset chip can be advantageous where cost can be driven down byproducing a higher volume of a single type of chip.

In other embodiments, the gate device acts mainly as a storage devicefor physiological information generated and transmitted by the patch.For example, the gate device can have a memory storage capability forstoring data transmitted wirelessly from the patch to the gate device.In this embodiment, the gate need not send data wirelessly, and thestored data can be retrieved via a physical connection to anotherdevice. For example, the gate device may have a removable memory device,or the gate device may have a connector which allows it to be connectedto another device in order to download the information on the gatedevice to another device, such as a medical device or computer.

One aspect of the invention is the management of power dissipation in awireless monitoring system in a real environment such as in a hospital,where the patch-ASIC chip, the base-ASIC chip, and the gate-ASIC chipwill end up at different distances from one another in differentcircumstances. For example, the power dissipation of the patch can bekept low by using low transmission power at the patch, and/or by using atransmitting in a mode, such as ultra-wideband (UWB) that uses lesspower. However, these power management solutions may only be successfulif the receiving device is close enough to the sending device and has asensitive enough receiving capability to reliably receive the signals.Thus in the present invention, the base-ASIC chip (and the μ-Base)generally have adequate power available to carry out more power andprocessor intensive functions, as the base-ASIC chip (and μ-Base) istypically deriving its power from either a plugged-in stationary device,or from a relatively large battery in a mobile or portable device;whereas the patch-ASIC chip must conserve its power because it is partof a patch which is generally small, light, and inexpensive, and thuswill only have a small battery with limited power and energy. The chips,patches, systems, and methods of the present invention provide for thebase-ASIC chip, the μ-Base, to use its power, resources, andfunctionality to lower the power output requirements of the patch-ASICchip, μ-Patch, and patch, thus extending the time over which the patchcan transmit patient data without recharging or replacing the battery,and ensuring secure and reliable communication with low powerdissipation.

Wireless Technology (Radio)

The devices, systems, and methods of the invention relate to the use ofwireless technology. As used herein, the term “wireless” refers to anysuitable method of communicating without the use of a hard-wiredelectrical connection. A hard-wired connection involves the directphysical connection of electrical conductors through which an electricalsignal flows. The distances over which the wireless communication occursmay be short (a few meters or less) or long (kilometers or greater). Theradio can be either ultra-wideband (UWB) radio or narrowband radio.Narrowband radio, as used herein, is any radio that is notultra-wideband (UWB) radio. For example, the Federal CommunicationsCommission (FCC) defines UWB as fractional bandwidth measured at −10 dBpoints where (f_high−f_low)/f_center >20% or total Bandwidth >500 MHz.Some examples of the narrowband radios suitable for the presentinvention are: Wi-Fi standard based radio, Bluetooth standard basedradio, Zigbee standard based radio, MICS standard based radio, and WMTSstandard based radio. Suitable wireless radio protocols include WLAN andWPAN systems.

ASIC Chips

The invention utilizes integrated circuits that are ASIC chips. An ASIC(Application Specific Integrated Circuit) is a system-on-chipsemiconductor device which is designed for a specific application asopposed to a chip designed to carry out a specific function such as aRAM chip for carrying out memory functions. ASIC chips are generallyconstructed by connecting existing circuit blocks in new ways. The ASICchips described herein are designed for the application of monitoring ofphysiological signals wirelessly. In some embodiments the ASIC chips ofthe invention comprise two or more ASIC chips that are designed to worktogether. In some embodiments, the ASIC chips of the present inventionare made using a bulk CMOS process. In some embodiments, the ASIC chipof the present invention encompasses end-to-end functionality with thefollowing features: Analog and digital sensor electronics formulti-sensor processing; a micro-controller based design to coordinateonboard resources and perform power-control; hardwired PHY and MACcoprocessors which enable highly integrated data-paths in smallsilicon-area, and a CMOS radio with built-in power amplifier.

In some embodiments, the ASIC chips comprise circuits for encryptionand/or decryption, for advanced encryption standard (AES), cyclicredundancy check (CRC), and/or forward error correction (FEC).

The ASIC chips of the present invention are designed to receive avariety of types of physiological signals. For example, the ASIC chipsof the invention can receive signals from ECG, EEG, EMG, SpO₂, tissueimpedance, heart rate, accelerometer, blood glucose, PT-INR, respirationrate and airflow volume, UWB radar, pressure, physical movement, bodyfluid density, patient physical location, or audible body sounds.

One aspect of the invention is an ASIC chip that is designed to receivesignals from multiple types of sensors. The capability of receivingdifferent types of signals can be important for the economics of theASIC chip for several reasons. For one, the cost per chip drops withvolume, and making a chip that can be used in multiple applicationsallows for higher volumes and therefore lower cost. In some cases thecapability of measuring multiple types of physiological signals is builtinto the ASIC chip, thus allowing the ASIC chip to be directly connectedto sensors without external signal conditioning. In some embodiments,the ASIC chip of the present invention has a programmable analogprocessor inside to program the ASIC to accept multiple physiologicalsignals.

One embodiment of the invention is an ASIC chip that is designed toreceive electrical physiological signals without the need for externalsignal conditioning. One embodiment of the invention is an ASIC chipthat is designed to receive any of ECG, EEG, EMG, SpO₂, tissueimpedance, heart rate, and accelerometer signals without the need forexternal signal conditioning.

The patch-ASIC chip of the present invention has the functionalityrequired to receive physiological signals from a sensor, to wirelesslytransmit the signals to a base device and in some cases to control thefunctionality of the patch. The patch-ASIC generally comprises at leasta sensor interface for measuring physiological signals, a processor forprocessing the signals into sensor data, memory for storing datarelating to the signals, a radio for transmitting sensor data, and powermanagement circuits for controlling power on the chip.

In some embodiments, the patch-ASIC is capable of receiving both analogand digital signals. In some embodiments, the patch-ASIC supports andcan receive signals from both passive and active sensing. Active signalsare signals that are created by injecting an output signal and measuringa response. Active signals include radio frequency signals, electrical,optical, and acoustic signals (such as for blood-oxygen, body-impedance,ultrasound, etc.).

The patch-ASIC generally has memory for storing physiological dataderived from the measured physiological signals. The data stored inmemory can be the data as received at the sensor, or the data that hasbeen processed. In some embodiments, the data is processed before beingstored. For example, in some embodiments, the data is filtered to removenoise from the sample before it is stored. In some embodiments, the ASIChas circuits for the manipulating the data from the physiologicalsignals. For example, circuits include, but are not limited to, digitalfiltering of sensor waveforms, lossless compression of sensor waveforms,and parameter extraction to identify onset of a disease condition (suchas identifying a particular type of arrhythmia). In some embodiments,different firmware is used to support different disease conditions. Anadvantage of disease condition parameter extraction is that it canconsiderably reduce the amount of data that needs to be transmitted tothe μ-Base, thereby reducing the radio power-consumption. A tradeoff isthe power consumed in performing the local processing and the increasedsilicon-cost in the form increased firmware memory or hardwareprocessing circuitry.

The patch-ASIC also generally has power management circuits designed tocontrol and minimize the energy used by the chip in carrying out itsfunctions. Power management circuits include, but are not limited to,clock-gating and protocol-level active, sleep and standby modes.

One use of the memory on the patch-ASIC is the use of the memory as abuffer to allow the decoupling of the receiving of signals and thetransmission of data. Memory allows the patch-ASIC chip, for example, tosubstantially continuously receive data, but to transmit the data at alater time as a burst. This allows for the use of less energy bylowering the amount of time spent transmitting.

One aspect of the patch-ASIC chip is its ability to be controlled by thebase-ASIC chip. The patch-ASIC chip is able to receive and respond toinstructions sent by the base device, such as instructions as to when tostore data and when to transmit, instructions on power levels, andinstructions on which radio mode to use (e.g. UWB or narrowband, orwhich narrowband frequency and protocol). In some embodiments, thepatch-ASIC chip is designed only to have UWB radio in order to lower itspower and energy output. A patch-ASIC with only UWB, and not narrowbandradio capability can be useful in scenarios where the μ-Gate or μ-Basecan be kept near the patch, for example, where the μ-Gate isincorporated into another patch on the same patient.

The patch-ASIC is generally incorporated into a μ-Patch. A μ-Patchcomprises a printed circuit board (PCB) to which the patch-ASIC isattached. The PCB also has an antenna attached that is in electroniccommunication with the patch-ASIC through the circuit board. The circuitboard may be rigid or flexible. The μ-Patch can also have additionalcomponents attached to the circuit board to enhance the functionality ofthe patch. For example, the μ-Patch can have a power amplifier foramplifying the signal from the patch-ASIC in order to increase the rangeof transmission by the antenna. The μ-Patch can also have additionalmemory chips attached to the circuit board to increase the memorystorage capacity of the patch. In the case where the patch performsactive sensing, the μ-Patch can have components attached to the circuitboard that facilitate the output of signals. The μ-Patch can have acomponent that is separate from the patch-ASIC chip that performsdigital signal processing (DSP). In some cases, the patch-ASIC chip canperform DSP, and the component that performs DSP enhances the DSPcapability of the μ-Patch. In some cases, the patch-ASIC chip does nothave DSP capability, and the component that performs DSP provides all ofthe DSP capability on the μ-Patch.

The base-ASIC chip of the present invention has the functionality forreceiving data from the patch or the gate device, transmitting the datato a host device, and for controlling the functionality of the patchand/or the gate devices over the air. The base-ASIC generally has atleast a processor for processing sensor data, memory for storing datarelating to the signals, a radio for transmitting instructions to thepatch-ASIC chip and to receive sensor data from it, power managementcircuits for controlling power on the chip, and a host interfaceallowing the base-ASIC chip to communicate with a host device. In someembodiments, the base-ASIC chip also has sensor inputs, allowing forsome sensor signals to be directly received by the base device through awired connection. The base-ASIC will generally have more processingpower than the patch-ASIC or gate-ASIC, allowing the base-ASIC toperform more power and processor intensive functions. In someembodiments, the base-ASIC will have the ability to do significantsignal processing and data analysis. In some embodiments, the base-ASICwill have the circuits for controlling the initialization and link setup, power management, data packet routing, type of transmission radio,radio transmit-power, radio receive-sensitivity, patch operationalintegrity, audio tone generation, display activation by the patch.

The base-ASIC is generally incorporated into a μ-Base (or MSP). A μ-Basecomprises a printed circuit board (PCB) to which the base-ASIC isattached. The circuit board may be rigid or flexible. The circuit boardgenerally also has an antenna that is in electronic communication withthe base-ASIC through the circuit board. The μ-Base can also haveadditional components attached to the circuit board to enhance thefunctionality of the base device. The μ-Base is described in more detailbelow.

Some embodiments comprise a gate-ASIC chip. The gate-ASIC in someembodiments is incorporated into a gate device. The gate-ASIC chip hasthe functionality for receiving data wirelessly from one or more patchesand for storing data in memory, and to forward the data wirelessly tothe μ-Base. The gate-ASIC generally has at least a processor forprocessing sensor data, memory for storing data relating to the signals,a radio for communicating with the patch-ASIC chip, and power managementcircuits for controlling power on the chip.

The gate-ASIC is generally incorporated into a μ-Gate. A μ-Gatecomprises a printed circuit board (PCB) to which the gate-ASIC isattached. The PCB also has an antenna that is in electroniccommunication with the gate-ASIC through the circuit board. The circuitboard may be rigid or flexible. The μ-Gate can also have additionalcomponents attached to the circuit board to enhance the functionality ofthe base device. For example, the μ-Gate can have a power amplifier foramplifying the signal from the gate-ASIC in order to increase the rangeof transmission by the antenna. The μ-Gate can also have additionalmemory chips attached to the circuit board to increase the memorystorage capacity of the gate device.

In some embodiments, the μ-Gate and the gate-ASIC chip can beincorporated into a patch. In these embodiments, the gate-ASIC chip willcomprise a sensor interface for receiving physiological signals.

In most embodiments, the ASIC chip of the present invention, forexample, the patch-ASIC chip, the gate-ASIC chip, or base-ASIC chip,comprise a single chip. In some embodiments, however, the ASIC chip canbe physically on two chips. For instance, an ASIC chip may comprisememory functionality or power amplifier functionality that physicallyresides on a second chip but is used functionally as if it were part ofa single ASIC chip.

In some embodiments, the patch-ASIC chip, the base-ASIC chip, and/or thegate-ASIC chip are manufactured as an ASIC superset wherein thefunctionality of all of the types of chips are on one chip, and thefunctionality that is not used on a given type of chip is turned off inthat chip. For example, in some cases the patch-ASIC chip and thebase-ASIC chip are made as a single ASIC superset wherein the base-ASICchip has a high power narrowband radio that is turned off in thepatch-ASIC chip.

In this application, we refer to a particular ASIC chip as communicatingwith another ASIC chip, as used herein communication with an ASIC chipis equivalent to there being communication through an ASIC chip, andgenerally means that data or information transferred from one ASIC chipreaches the other ASIC chip in some form. It is understood that the ASICchips will generally communicate through antennae, and or othercomponents.

Physiological Patch

The present invention relates to physiological patches for themeasurement of signals relating to a physical parameter in a patient,and the transfer of data relating to the measured physical signals to aremote location. The patches of the present invention communicatewirelessly with a base device or with a gate device or both a base and agate device.

In some embodiments, the patch includes one or more sensors incorporatedinto the patch. In other cases, the patch does not include sensors, butis connected to the sensor by wires, and receives physiological signalsfrom the sensor through the wires. In some cases, the patch includes oneor more sensors, and in addition, is connected by wires to other sensorsthat do not reside on the patch.

The patches of the present invention are generally wearable. In somecases they are held onto the skin with an adhesive. In some cases, forexample, where an electrical signal is being measured, e.g. for ECG orEEG, some or all of the adhesive is electrically conducting, for examplecomprising silver and or silver chloride. In other cases, the adhesiveis electrically non-conductive. The patch adhesive can be either wet ordry. In some cases, the patch can be held in place with straps or clipsor may be incorporated into a piece of wearable clothing such as a hat,gloves, socks, shirt, or pants. In some cases, the patch is implanted.For multiple Patches, for example for EEG monitoring, the patches can bekept together (in sort of a shower-cap) so that they can be applied overthe head together.

The patches may be placed on any suitable part of the body depending onthe physiological signal and the condition to be measured. For ECGmonitoring, for example, in some embodiments, a single patch can beused, the patch is placed on the upper-chest area. For EEG monitoring,e.g. for monitoring sleep Apnea, multiple patches are placed on thehead.

The patches will generally be placed in direct contact with the body.This will be the case for embodiments in which electrical physiologicalsignals are measured, and where the patch incorporates the sensor. Inother embodiments, the patch is in proximity of the body, but not indirect contact. For example, there may be no need for direct contact forapplications such as the measurement of SpO₂ where the patch may beplaced next to a finger-tip assembly consisting of the LED/photodiodecombination.

In some embodiments, the patch consists of the patch-ASIC, with multiplemetal-electrodes (along with electrode-gel) on one side to pickup sensorsignals from the body, and PCB trace antenna on the output side of thepatch to radiate the radio (RF) signal. A suitable patch of this type ofpatch is described in co-pending U.S. Patent Application 60/940,072, andU.S. Patent Application 60/943,539, which are incorporated by referenceherein in their entirety.

In some embodiments, the patch-ASIC has built-in sensor-signalprocessing for physiological signals such as ECG and EEG. In someembodiments, sensor-signal processing is provided by components withinthe patch, but not included on the ASIC. For example, circuitry such asanalog amplification and filtering can be on the patch in separatecomponents. The additional components can be used for example for activesensing applications such as blood-oxygen level (SpO2), which requireoutputs to drive light emitting diodes (LEDs, e.g. red/infra-red) whoselight is usually passed through a finger-tip and captured by aphotodiode and fed back to the ASIC for further processing. Thefinger-tip sensor-assembly (LEDs and photodiode) is generally notincorporated into the patch itself. There will generally be dedicatedinputs/outputs on the patch to connect to this sensor assembly, and/orto similar sensor assemblies. Digital sensor signals can also be inputto the Patch, and processed by the ASIC. One aspect of the invention isa patch that is capable of measuring ECG, EEG, EMG, SpO₂, tissueimpedance, heart rate, accelerometer, blood glucose, PT-INR, respirationrate and airflow volume, UWB radar, pressure, physical movement, bodyfluid density, patient physical location, and audible body sounds. Insome embodiments the patch comprises an ASIC that can measure ECG, EEG,EMG, SpO₂, tissue impedance, heart rate, and accelerometer signalswithout external signal conditioning.

In some embodiments, the patch is a cardiac patch that can measure allof ECG, SpO₂, tissue impedance, accelerometer, and PT-INR signals. Insome embodiments, the patch is a neurological patch for measuring sleepapnea that can measure all of EEG, EMG, SpO₂, heart rate, respirationrate and airflow volume, and pressure signals. In some embodiments, thepatch is an endocrinalogical patch for measuring diabetes/wound that canmeasure all of ECG, blood glucose, and UWB radar signals. In someembodiments, the patch is a fitness and wellness patch that can measureall of ECG, heart rate, accelerometer, and pressure signals.

In some embodiments, the patch includes a PCB antenna, battery,sensor-electrodes, as well as the electronics section comprising theμ-Patch with patch-ASIC and other electronic components. The electrodessection and electronics section are typically manufactured separatelyand assembled together, along with the battery. In some embodiments, theelectrodes section is flexible, and the electronics section issemi-rigid or flexible. In some embodiments, both sections are massproduced, machine assembled and tested. The term “batteries” willgenerally be used herein but it is to be understood that generallyanother power source other than a battery could also be used.

The patches of the invention generally have a power source incorporatedinto the patch. The battery is electrically connected to the patch-ASICchip. The power source can be any suitable power source. The powersource is typically a battery such as Li-ion, NiCD, NiMH, or Zn-airbattery. In some embodiments, the power source can be a source otherthan a battery, for example, an ultracapacitor, micro-fuel cell,micro-heat engine, or radioactive power source. Because the patch isgenerally meant to be worn, the battery should be small and light. Insome cases, the battery is removably attached the patch. In some cases,the battery is substantially irreversibly attached to the patch, forexample, soldered onto the PCB of the μ-Patch. In some cases the batteryis rechargeable, for example magnetically rechargeable withoutelectrical contact with the recharging device.

In some embodiments, the patch comprises an alert incorporated into thepatch. The alert can provide the user, for example, with informationabout the state of the patch, the proper placement of the patch, thedistance of the user from the base device, the state of the battery inthe patch, or the time the user has been outside of a communicationrange with the base device. The alert can also be used to inform theuser of a particular health condition or of a recommended action to takedue to the measured physiological signals. For example, the alert can beused to recommend that the patient take a medication and/or to contactmedical professionals. The alert can be, for example, audio, visual, orvibration based. In some cases, the alert is at the base or gate device.The audio alert can be, for example, a small speaker that either beepsor chimes to alert the user, or may have more complex audio outputincluding using language to communicate with the user. A visual alertcan be, for example, a flashing or constant light such as an LED, or cancomprise a display that displays signals to the user, such as a liquidcrystal display capable of displaying alpha-numeric characters.

In one embodiment, an alert on the patch (or on the base or gate) isused to provide confirmation of proper patch placement to the user atthe time of patch placement. For example, the patch may monitor testsignals to confirm correct placement. The confirmation of correctplacement can be carried out in some cases by the patch, and in somecases with a combination of the base device and the patch, e.g. byholding the base device near the patch. An audio-alert at the Patchcould be used for when a patient goes out of the effective range of aμ-Base.

In some embodiments, the patches of the present invention are disposableafter use. For example, electrodes with wet/dry gel may be non-reusableonce they are peeled-off the body, thus a patch comprising electrodesensors would generally be disposed of after use. In other embodiments,the patch is manufactured in a two-piece configuration such that theelectrodes in one piece are disposable, but the μ-Patch with thepatch-ASIC and associated electronics in another piece is reusable byconnection to another electrode bearing piece.

It is generally desired that the patches be comfortable to wear, andthus the patches of the invention are typically small. In someembodiments the patches are relatively thin and flat, so as to be placedon the surface of the body. In some embodiments portions of the patchare flexible to conform to the body. In some embodiments, the patchesare less than about 30 cm² in area. In some embodiments, the patches areless than about 20 cm² in area. In some embodiments, the patches areless than about 10 cm² in area. In some embodiments, the patches areless than about 5 cm² in area. In some embodiments, the patches are lessthan about 2 cm thick. In some embodiments, the patches are less thanabout 1 cm thick. In some embodiments, the patches are less than about0.5 cm thick. In some embodiments, the patches are less than about 0.2cm thick.

In some embodiments, the patches are less than about 30 cm² in area andless than about 1 cm thick. In some embodiments, the patches are lessthan about 20 cm² in area and less than about 1 cm thick. In someembodiments, the patches are less than about 20 cm² in area and lessthan about 0.7 cm thick. In some embodiments, the patch compriseselectrodes for measuring ECG and is about 15 cm² to about 25 cm² in areaand about 0.5 cm to about 1 cm thick.

In some embodiments, the patches have a volume of less than about 30cm³. In some embodiments, the patches have a volume of less than about20 cm³. In some embodiments, the patches have a volume of less thanabout 15 cm³. In some embodiments, the patches have a volume of lessthan about 10 cm³. In some embodiments, the patches have a volume ofless than about 5 cm³.

One aspect of the invention is a patch, used as part of a system thathas relatively low volume as that described above but can monitor andtransmit data for relatively long periods of time without having toreplace or recharge the batteries.

In some embodiments, devices, systems and methods of the inventionprovide a patch that can wirelessly transmit data while monitoring aphysiological signal from a patient for at least about 1, 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 14, 17, 21, 28 or more than 28 days withoutchanging or recharging the batteries. In some embodiments, the patch canwirelessly transmit data while substantially continuously monitoring aphysiological signal from a patient for at least about 1, 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 14, 17, 21, 28 or more than 28 days withoutchanging or recharging the batteries.

As referred to herein, a patch is substantially continuously monitoringa physiological signal when it is sampling the physiological signal atregular intervals where the sampling rate is such that the physiologicalcondition is effectively monitored over the time period. The frequencyof sampling will depend on the particular physiological condition thatis monitored, and the time frame during which a meaningful measurableevent will occur. In some cases the appropriate rate can be determinedby using the Nyquist rate. The Nyquist rate is the minimum sampling raterequired to avoid aliasing, equal to twice the highest modulationfrequency contained within the signal. In other words, the Nyquist rateis equal to the two-sided bandwidth of the signal (the upper and lowersidebands). For example, for measuring ECG signals, the relevantphysiological signal information occurs at a rate of about 100 Hz, thusthe sampling should be at a minimum of about 200 Hz. In some cases, itis prudent to sample at a rate higher than the Nyquist rate. In someembodiments of the invention, the physiological signal that iscontinuously monitored is an ECG measurement which is continuouslysampled at a rate of 200 Hz to 800 Hz. In some embodiments of theinvention, the physiological signal that is continuously monitored is anECG measurement which is continuously sampled at a rate of 300 Hz to 500Hz. In some embodiments of the invention, the physiological signal thatis continuously monitored is an ECG measurement which is continuouslysampled at a rate of about 400 Hz. The term substantially continuousincludes situations where the measurement is interrupted for a fractionof the time of the measurement. For example a substantially continuousmeasurement would occur if the continuous measurement occurred over asubstantial period of the time of measurement.

In some embodiments, the patch can wirelessly transmit data whilemonitoring a physiological signal from a patient for at least about 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 21, 28 or more than 28 dayswithout changing or recharging the batteries where the battery in thepatch with a type of battery that provides, on average, less than about50, 100, 150, 200, 250, 300, 400, 600, 800, 1000, or 1200 mA-hours.

In some embodiments, the patch can transmit about 1, 2, 5, 10, 15, 20,25, 30, 35, 37, 40, 50, 60, 75, 90, 100, 500 or more than 500 KB or 1,2, 5, 10, 15, 20, 25, 30, 35, 37, 40, 50, 60, 75, 90, 100 or more than100 MB of data per day while monitoring a physiological signal from apatient for at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14,17, 21, 28 or more than 28 days without changing or recharging thebatteries. In some embodiments, the patch can transmit about 5 MB ofdata per day while monitoring a physiological signal from a patient forat least about 2 days without changing or recharging the batteries. Insome embodiments, the patch can transmit about 10 MB of data per daywhile monitoring a physiological signal from a patient for at leastabout 2 days without changing or recharging the batteries. In someembodiments, the patch can transmit about 20 MB of data per day whilemonitoring a physiological signal from a patient for at least about 2days without changing or recharging the batteries. In some embodiments,the patch can transmit about 50 MB of data per day while monitoring aphysiological signal from a patient for at least about 2 days withoutchanging or recharging the batteries. In some embodiments, the patch cantransmit about 5 MB of data per day while monitoring a physiologicalsignal from a patient for at least about 4 days without changing orrecharging the batteries. In some embodiments, the patch can transmit atleast about 20 MB of data per day while monitoring a physiologicalsignal from a patient for at least about 7 days without changing orrecharging the batteries. In some embodiments, the patch can transmit atleast about 20 MB of data per day while monitoring a physiologicalsignal from a patient for at least about 14 days without changing orrecharging the batteries.

In some embodiments, the patch can transmit at least about 1, 2, 5, 10,15, 20, 25, 30, 35, 37, 40, 50, 60, 75, 90, 100, 500 or more than 500 KBor 1, 2, 5, 10, 15, 20, 25, 30, 35, 37, 40, 50, 60, 75, 90, 100 or morethan 100 MB of sensor data per day at a range of up to about 30 m whilemonitoring a physiological signal from a patient for at least about 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 21, 28 or more than 28 dayswithout changing or recharging the batteries. In some embodiments, thepatch can transmit at least about 5 MB of sensor data per day at a rangeof up to about 30 m while monitoring a physiological signal from apatient for at least about 2 days without changing or recharging thebatteries. In some embodiments, the patch can transmit at least about 10MB of sensor data per day at a range of up to about 30 m whilemonitoring a physiological signal from a patient for at least at leastabout 2 days without changing or recharging the batteries. In someembodiments, the patch can transmit at least about 20 MB of sensor dataper day at a range of up to about 30 m while monitoring a physiologicalsignal from a patient for at least about 2 days without changing orrecharging the batteries. In some embodiments, the patch can transmit atleast about 50 MB of sensor data per day at a range of up to about 30 mwhile monitoring a physiological signal from a patient for at leastabout 2 days without changing or recharging the batteries. In someembodiments, the patch can transmit at least about 10 MB of sensor dataper day at a range of up to about 30 m while monitoring a physiologicalsignal from a patient for at least about 4 days without changing orrecharging the batteries. In some embodiments, the patch can transmit atleast about 10 MB of sensor data per day at a range of up to about 30 mwhile monitoring a physiological signal from a patient for at leastabout 7 days without changing or recharging the batteries. In someembodiments, the patch can transmit at least about 10 MB of sensor dataper day at a range of up to about 30 m while monitoring a physiologicalsignal from a patient for at least about 14 days without changing orrecharging the batteries.

In some embodiments, the patch uses less than about 1, 2, 3, 4, 5, 6, 7,8, 9, 10, 15, 20 mW of power on average. In some embodiments the patchhas a volume that is less than about 20, 30, 40, 50, or 60 cm³ and usesless than about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 mW of power onaverage. In some embodiments, the patch has a volume that is less thanabout 30 cm³ and uses less than about 10 mW on average. In someembodiments, the patch has a volume that is less than about 30 cm³ anduses less than about 6 mW on average. The volume of the patch can becalculated in some cases, for example, where the patch is in the shapeof a disk, by multiplying the area of the patch by the thickness of thepatch.

The term “sensor data” is used to describe the amount of datatransmitted from the patch to the μ-Base. In this context sensor datameans the data that is sent from the patch that directly correlates withthe physiological signal and excludes data sent, for example as part ofan encryption scheme.

Base Device (μ-Base)

One aspect of the invention is the base device which comprises a μ-Basewhich includes a base-ASIC chip. The base-ASIC is generally incorporatedinto a μ-Base (or MSP). A μ-Base comprises a printed circuit board (PCB)to which the base-ASIC is attached. The circuit board may be rigid orflexible. The circuit board generally also has an antenna that is inelectronic communication with the base-ASIC through the circuit board.The μ-Base can also have additional components attached to the circuitboard to enhance the functionality of the base device. The μ-Basereceives sensor data from one or more patches and or gate devices. Theμ-Base generally processes the sensor data, and sends the processedsensor data to a host device. In addition, the μ-Base controls functionsof the patch including supervising power management and controlling dataflow.

The host device is a device which can host a μ-Base module. In someembodiments, the μ-Base is incorporated into host device, and can forexample, be fully integrated within the host. The base-ASIC can besoldered onto a board within a host device such as mobile medicalmonitor which provides power to the base-ASIC chip and may provide otherfunctionality such as an antenna. In some embodiments, the μ-Base can beeither connected to the host as an external device via a host interfacebus. In some embodiments, the μ-Base is incorporated into a device, suchas a card that connects with the host device. In some embodiments, theμ-Base is incorporated into an adaptor which connects to the hostdevice. The μ-Base adaptor can connect to the host device by anysuitable input or input/output port. In some embodiments, the μ-Baseconnects to the host device through a serial port with an interface suchas USB or SDIO.

The host devices can be any suitable stationary, portable, or mobiledevice or a stationary, portable, or mobile medical instrument. Examplesof host devices include a cellular phone, pager, i-Pod™, PDA, watch, orother mobile device, laptop, notebook, palm-top, or desk-top computer,or a medical instrument. Suitable medical instruments include medicalinstruments for monitoring health conditions by measuring physiologicalsignals such ECG, EEG, EMG, SpO₂, tissue impedance, heart rate,accelerometer, blood glucose, PT-INR, respiration rate and airflowvolume, UWB radar, pressure, physical movement, body fluid density,patient physical location, or audible body sounds. The medicalinstrument can be stationary, desk-top, portable, or mobile. One aspectof the invention involves using a μ-Base incorporated into an adaptor inorder to allow a medical instrument designed to measure sensor datathrough wired connections to measure similar sensor date through awireless connection. This allows for conversion of a wired-sensormedical device into a wireless sensor medical device. In someembodiments, the adaptor connects to the medical device through the sameconnectors to which the wired sensors were connected. In other cases,the μ-Base adaptor connects to the medical device through another porton the medical device. For example, where a medical device was designedto measure pulse-rate with wired sensors that connect directly into themedical device, the μ-Base adaptor could plug into the jacks into whichthe wired sensors are designed to be connected. In this case, the μ-Basewould receive the wireless signal from the μ-Patch, convert the signalif needed and send the signal to the medical instrument. Alternatively,the μ-Base adaptor could be made to plug into another port such as a USBport on the medical instrument. In this case, the μ-Base would convertthe wireless signals from the μ-Patch into signals appropriate fortransmission via this port. The μ-Base adaptor form-factor depends onthe host-device as well as application. It can be, for example ofUSB-stick or mini-SD.

In some embodiments, the μ-Base will derive its power from the hostdevice. In some embodiments, the μ-Base will have associated powersources such as batteries. The μ-Base will generally have more energyavailable to it than the μ-Patch. The present invention allows for theμ-Base to perform the more power and processor intensive functions,conserving the energy usage of the μ-Patch.

One aspect of the invention is the utilization of the μ-Base as a masterdevice, where the μ-Base can test, control, and monitor the functions ofμ-Patches and/or μ-Gates by sending and/or receiving test signals and/orcontrol signals. Examples of functions that are controlled by the μ-Baseinclude initialization and link set up, power management, data packetrouting, type of transmission radio, radio transmit-power, radioreceive-sensitivity, patch operational integrity, audio tone generation,display activation, or a combination thereof.

In some embodiments, a network made up of the μ-Base, μ-Patch(es), andμ-Gate(s) work on a packet-data protocol. Using this network, μ-Basekeeps track of the link-quality of various wireless links between theμ-Base, μ-Patch(es), and μ-Gate(s) and takes corrective actions asneeded. For example, if the link from a μ-Patch to one of the μ-Gatedegrades too much, the μ-Base can send a command to the μ-Patch toswitch its link to a standby μ-Gate for better link quality.

In some embodiments, the μ-Base can instruct the μ-Gate to switch from aUWB radio to narrowband radio depending on certain signal qualityparameters. In the absence of strong narrowband interference, forinstance, UWB link is used. When strong narrowband interference isdetected (thereby degrading link quality), a narrowband link is usedwith a different narrowband carrier until the narrowband interfererdisappears. The link is then switched back to UWB. This scheme resultsin lower overall power consumption because UWB radio consumes lesspower. Systems for wireless communication using multiple radios isdescribed in co-pending U.S. Patent Application 60/894,174, U.S. PatentApplication 60/894,093, and U.S. Patent Application 60/943,540 which areincorporated by reference herein in their entirety.

In some embodiments, the μ-Base can also control μ-Patch transmit powerby issuing commands to reduce/increase transmit power depending on thereceive signal strength. This helps save energy and provides higherreliability. The μ-Base can also issue commands to μ-Patch(es) to gointo sleep-modes to conserve power.

In some embodiments, the μ-Base sends periodic commands to instructμ-Patch(es) to transmit data. Implementing the power-control algorithmson the μ-Base helps simplify the μ-Patch implementation, reducing costand power.

In some embodiments, the μ-Base performs duty-cycle control. Forexample, the μ-Base performs clock-gating with protocol-level sleepmodes to reduce power dissipation. For example, during RF transmission,the receive-section is turned off and during RF reception, thetransmit-section is turned off. During silent periods, only thefront-section of the radio receive-chain stays on to listen for packetsmeant for the particular Patch, and wakes-up the rest of the receiverwhen it detects them.

In some embodiments, the μ-Base performs functional allocation on theμ-Patch, and/or μ-Gate. The μ-Base can dynamically alter the performanceof the functional blocks. For example, receiver sensitivity and transmitphase-noise can depend on the biasing of the RF circuitry, which in turnaffects power-consumption. When a transmitter is nearby, the receiverdoesn't need high sensitivity, so it can reduce it by reducing the bias,saving power. Similarly, in a low interference environment, higherphase-noise could be tolerated, saving power. In addition, lower energyuse by the patch is achieved by using asymmetric schemes that requiremore powerful coding and modulation schemes with more complex receiveprocessing on the μ-Base, while requiring simple transmit-processing onthe μ-Patch. More powerful receive processing on the μ-Base include, forexample turbo-decoding (forward error-correction) and smart-antennaschemes. These schemes lessen the burden for the μ-Patch to transmithigh-power to maintain a reliable communication-link, thus savingenergy. Suitable smart antenna schemes are described in co-pending U.S.Patent Application 60/943,538 which is incorporated by reference hereinin its entirety. The smart antenna schemes can use beam-formingtechniques, and can involve data processing to enhance signal to noise.In some embodiments, the smart antenna scheme on the μ-Base comprisesmore than one antenna. In some embodiments, the smart antenna scheme onthe μ-Base comprises two or more antennae. In some embodiments, thesmart antenna scheme on the μ-Base comprises 4 or more antennae. In someembodiments, the smart antenna scheme on the μ-Base comprises 2, 3, 4,5, 6, 7, 8, 12 or more than 12 antennae. In some embodiments, the smartantenna scheme on the μ-Base comprises about 4 antennae.

In some embodiments, the μ-Base performs authentication of patches atthe time of their placement on the body and their initialization. Bybringing the μ-Patch close to the μ-Base at the time of placement,private user-specific key can be transferred from the μ-Base to theμ-Patch. In some cases, by being close to the μ-Patch, the μ-Base cantransmit the key at very low-power so that other devices cannot listento the key transmission. By using this activeauthentication/initialization process by the μ-Base, long sequences ofμ-Patch discovery and authentication similar to generic wirelessnetworks is avoided, thereby saving power.

In some embodiments, the patch-ASIC on the μ-Patch comprises an encodingscheme for encoding transmission, and the base-ASIC chip on the μ-Basecomprises both an encoding scheme and a decoding scheme, wherein thedecoding scheme on the μ-Base is more power and processor intensive thanthe encoding scheme on the μ-Patch. In some embodiments, the encryptionscheme uses shared keys, wherein the device comprising the base-ASICchip wirelessly writes the shared keys to the patch. In someembodiments, the patch-ASIC chip has a simple turbocode encoder, and thebase-ASIC chip has the more complex turbocode decoder. In someembodiments, the encryption scheme is an Advanced Encryption Standard(AES) scheme, where the decryption part of the scheme resides on thebase-ASIC chip.

Gate Device (μ-Gate)

One aspect of the invention is the gate device which comprises a μ-Gatewhich includes a gate-ASIC chip. The gate device is generally a smallportable device that can easily be kept on or near the user. Forexample, the gate device can be of the size that can be comfortably keptin a pocket. In some embodiments, the gate device could have, forexample, the area of a credit card, about 2 inches by about 3 inches,and less than about 0.5 inches thick. In some cases, the gate device canact as an intermediary device between the μ-Base and the μ-Patch. Inother cases, the gate device can act primarily as a memory storagedevice, to store data transmitted by the patch. In some embodiments, theμ-Gate can be incorporated into a patch where it can act as a higherperformance patch where it can perform physiological sensing functionslike a regular patch comprising a patch-ASIC. For example, the patchcomprising the μ-Gate can act as a gateway for multiple other patches onthe same patient. The patch comprising the μ-Gate can, for example, havethe capacity to communicate in either UWB or narrowband with the μ-Base,and may have a larger memory capacity and a larger battery than theother patches. The other patches comprising patch-ASICs can operate atlower power by, for example communicating only by UWB with the μ-Gatewhich will always be close to the patches if placed on the same patient.The μ-Gate, however, will have the capacity to manage communication withthe μ-Base, which may sometimes be farther away from the μ-Gate,necessitating, for example communication by narrowband which requiresmore power and energy and/or the storage of larger amounts of data onthe μ-Gate. The μ-Gate can collect data from other patches to send to aμ-Base.

For example, in a system with multiple patches, the gate devices areintroduced to aggregate the μ-Patch sensor data (wirelessly) and thentransmit it to the μ-Base (essentially acting as gateways). This allowsthe μ-Patches to spend much less energy to reliably transmit data to anon-body or nearby μ-Gate device as opposed to a μ-Base device that couldbe tens of meters away. In some cases a redundant (standby) μ-Gates isused for reliability in case the primary μ-Gate is unreachable by eitherμ-Patches or μ-Base. The standby μ-Gate can also be used asload-balancer and data backlog remover when links of multiple patches tothe primary μ-Gate degrade temporarily, and there is a need to catch upwith clearing the buffered data in Patches by sending it to the μ-Baseusing both primary and secondary μ-Gates.

One aspect of the invention is a system for monitoring physiologicalsignals comprising two or more ASIC chips wherein the chips are designedto work together to measure physiological signals, comprising: (a) apatch-ASIC chip for incorporation into a physiological signal monitoringpatch comprising a sensor interface for measuring physiological signals,a processor for processing the signals into sensor data, memory forstoring data relating to the signals, a radio for transmitting sensordata, and power management circuits for controlling power on the chip;and (b) a base-ASIC chip comprising a processor for processing sensordata, memory for storing data relating to the signals, a radio fortransmitting instructions to the patch-ASIC chip, power managementcircuits for controlling power on the chip, and a host interfaceallowing the base-ASIC chip to communicate with a host device. Generallythe base-ASIC chip is incorporated into a μ-Base and the patch-ASIC chipis incorporated into a μ-Patch, wherein both the μ-Base and the μ-Patchcomprise a printed circuit board and an antenna attached to the printedcircuit board for transmitting radio signals.

In some embodiments, the base-ASIC acts as a master device to control afunction of the μ-Patch or the μ-Gate or both the μ-Patch and theμ-Gate. Examples of functions controlled by the base-ASIC areinitialization and link set up, power management, data packet routing,type of transmission radio, radio transmit-power, radioreceive-sensitivity, patch operational integrity, audio tone generation,display activation, or a combination thereof.

FIG. 7 shows an exemplary system that includes a μ-Gate. The system hasmultiple μ-Patches (μP) that are placed on the body of a patient. Thesystem has a μ-Base, which in this embodiment is shown as beingincorporated into a host device in the form of a cellular phone or PDA.The μ-Base can be incorporated either directly as an integral part ofthe host device or as part of an adaptor, such as a card that plugs intothe host device. The system depicted has more than one μ-Gate that cancommunicate with the μ-Patches. In the system shown in FIG. 7, theμ-Gates are acting as intermediary devices that receive data from theμ-Patches and send data to the μ-Base. In addition, in some embodiments,the μ-Gates can receive and relay instructions from the μ-Base to theμ-Patches. In some cases, multiple μ-Gates can be used to provide abackup for receiving information from the μ-Patches, either to enhancethe communication link by using, for example, the closest μ-Gate, or byenhancing the utilization of memory capacity. FIG. 7 shows that thesystem may also have an optional remote server which receivesinformation related to the sensor data from the host device. In somecases, the remote server is a secure server that has other patient datato which the data from the host device can be added.

In some embodiments the host-device further communicates with a secureserver to which information derived from the physiological sensors istransmitted. The transfer of information from the host device can bewireless, or by direct wired connection. Connection to theremote-monitoring server from the μ-Base or host-device would depend onthe type of network connection the host-device has. It could be Wi-Fi(WLAN), cellular-data (GPRS/3G-CDMA), wired LAN/WAN(Ethernet/DSL/Cable), or wireless broadband WAN (WiMax). The secureserver can, for example, integrate the information from the host devicewith other patient information.

The system of the present invention allows for the reliable and securetransmission of information related to a patient's condition.Reliability is the ability to transfer information accurately. In someembodiment, reliability is enhanced through schemes to make the wirelesslink reliable; for example by forward error-correction,packet-retransmission (automatic repeat-request or ARQ) andsmart-antenna techniques on the receiver side. Retransmission requiresbuffering of data on the transmit side (as well as on the receive sidewhen packets are received out of sequence). Interference from otherusers wearing similar patches is avoided by either frequency-hoppingtheir carrier-frequencies in a pseudo-random fashion, or modulatingtheir data with different pseudo-random code sequences with lowcross-correlation properties.

Security relates to the ability of the system to keep the contents ofthe wireless transmission indecipherable to the third-party. In someembodiments of the invention, security is enhanced through encryptionsuch as 128-bit AES (Advanced Encryption System) encryption. Packets areencrypted on the transmit side and decrypted on the receive side using aset of shared-keys. In one embodiment, the base device wirelessly writesthese keys to the patch during initialization by placing the μ-Base andμ-Patch next to each other to prevent third-party listening. The keyscan be made unique by virtue of unique ID's associated with each user.

The systems of the invention include continuous, periodic, or episodicmeasurement of a physiological condition. For example, one embodiment ofa continuous monitoring scheme is a wireless Holter monitor. A Holtermonitor is a portable device for continuously monitoring the electricalactivity of the heart, typically for 24 hours or more. Its extendedrecording period is sometime useful for observing occasional cardiacarrhythmias that would be difficult to identify in a shorter period oftime. For patients having more transient symptoms, a cardiac eventmonitor which can be worn for a month or more can be used. The Holtermonitor of the present invention records electrical signals from theheart via a one or more patches, each comprising μ-Patch with apatch-ASIC. The patches have electrodes that are typically attached tothe chest. The number and position of patches with electrodes can vary,for example from one to eight. The patches monitor the electricalsignals from the patient and transmit the sensor data to a μ-Base thatis in a device that is kept on the patient, for example attached to abelt or kept in a pocket and is responsible for keeping a log of theheart's electrical activity throughout the recording period. The systemsof the invention can perform episodic monitoring, in which a particularevent is detected, either manually or automatically. An example ofepisodic monitoring is a cardiac event-monitor. In episodic monitoring,the μ-Base can control the μ-Patch, so that the patch performs onlyminimal sensor signal processing to detect the particular event, thenmonitors and stores physiological signals after event detection. Theradio-section of the Patch would generally be turned off while waitingfor the event. The systems of the present invention can also performperiodic monitoring wherein the μ-Patch measures and stores data relatedto physiological signals at a given time interval. In some embodiments,the μ-Base keeps track of the time intervals and instructs the μ-Patchwhen to measure signals and store data. Examples of periodic monitoringby the system of the present invention are blood-pressure orblood-glucose-monitoring. The time period between monitoring intervalsfor periodic monitoring can be from seconds to days. Generally, the timeperiod between monitoring intervals for periodic monitoring is on theorder of minutes to hours. For example, periodic monitoring for bloodpressure could be every 10 to 30 minutes, and periodic monitoring ofblood glucose could be every few hours.

In some embodiments, the systems of the present invention can be used instand-alone mode. In stand alone mode a μ-Patch or μ-Gate will monitorand record sensor signals and store sensor data in a local memory. Oncethe observation period is completed, the stored data is transferred to aserver-type machine for further analysis.

Asymmetric Distribution of Processing

One aspect of the invention relates to systems and methods in which theprocessing is distributed unequally or asymmetrically over differentchips that are designed to work together. In some embodiments, theasymmetric system incorporates one or more patch-ASIC chips and abase-ASIC chip. In other embodiments the system also incorporates one ormore gate-ASIC chips. All of these chips are designed to work together.In general, the system is designed such that the base-ASIC chip has moreprocessing resources and therefore carries out more processing than thepatch-ASIC chip or the gate-ASIC chip. In some embodiments, thebase-ASIC chip will take on most or all of the processing of a certaintype, allowing the system to function such that the patch-ASIC and/orgate-ASIC can function effectively using less energy, allowing them torun on small batteries for long periods of time without having toreplace or recharge the batteries or replace the patch or gate.

In one aspect, the base-ASIC chip has more resources to implement thephysical layer of the basic radio than the patch-ASIC chip. Theresources devoted to the physical layer of the base radio include: thebaseband signal processor, the data encoder/decoder, and the radiofrequency transceiver. In some cases, the base-ASIC chip has moreresources to implement media access control (MAC) functions that allowsdata interface to the radio's physical layer than does the patch-ASICchip. In some cases the base-ASIC chip has more resources to runalgorithms to monitor the radio environment and facilitate thecoordination of multiple radios than the patch-ASIC does. In some casesthe base-ASIC chip has more resources for multiple antenna signalprocessing to increase the link reliability than does the patch-ASICchip. In some cases, the base-ASIC chip has more resources to supervisethe proper functioning of the overall radio link and network than thepatch-ASIC chip. In some cases the base-ASIC chip has more resources forpower management than the patch-ASIC chip.

In some embodiments, the base-ASIC chip has more processing resourcesfor one of the types of processing resources described above. In someembodiments, the base-ASIC chip has more processing resources for to 2,3, 4 or more of the types of resources described above than thepatch-ASIC chip. In some embodiments, the base-ASIC chip has moreprocessing resources for all of the types of resources described above.For example, in some cases, the base-ASIC chip has more resources toimplement the physical layer of the basic radio, more resources toimplement media access control (MAC) functions that allows datainterface to the radio's physical layer, more resources to runalgorithms to monitor the radio environment and facilitate thecoordination of multiple radios, more resources for multiple antennasignal processing to increase the link reliability and more resources tosupervise the proper functioning of the overall radio link and networkthan the patch-ASIC chip.

In some embodiments, the base-ASIC chip has more processing resourcesthan the patch-ASIC chip because the base-ASIC chip has highercomplexity radio receivers and transmitters than those in the patch-ASICchip. A typical radio transmitter or receiver generally contains threeprimary functions: Data Codec (Coder/Decoder), Baseband signalprocessor, and Radio Frequency (RF) transceiver. In some embodiments thebase-ASIC chip has higher more processing power in one, two, or allthree of these functions than the patch-ASIC chip. As used herein, aData Codec (Coder/Decoder) refers to the encoding of data to betransmitted on the transmitter side to increase the system reliability.One example of Data Codec is Turbo coding. Correspondingly, the receiveddata on the receiver side is decoded, for example, with a Turbo Decoder.A baseband signal processor performs various functions such asmodulation/demodulation, equalization, and timing recovery. On thetransmitter side, a carrier wave is modulated using a chosen scheme(e.g. QAM, BPSK) to produce a baseband signal for the transmission. Thereceiver performs corresponding demodulation functions on the receivedbaseband signal. In addition the receiver performs various otherfunctions such as equalization. A radio frequency (RF) transceivertransmits and receives radio signals. The RF transmitter can modulate aRF carrier wave with baseband signal for transmission through an antenna(up-conversion). Simpler transmitters, generally used on the patch-ASICchip, can perform the up-conversion in one step and complex schemes,such as those employed on the base-ASIC chip, may include multiple stepswith intermediate frequencies. On the receiving end, the reverse processtakes place—down-conversion of the RF signal to baseband signal.

In addition, the radio can optionally contain additional blocks. Forexample, the radio may contain a processor to monitor the radioenvironment and coordinating the functionality of radios, a multipleantenna signal processor, and power control. These blocks can reside onthe transmitter side, the receiver side or distributed on both sides.For the systems and methods of this invention, these blocks aregenerally contained mostly or substantially completely on the base-ASICchip.

The low complexity transmitter utilized on the patch-ASIC chip performsthe minimum needed functions form the above using simple circuits. Thepatch-ASIC chip/base-ASIC chip system is designed in order to push thecomplexity to the corresponding receiver on the base-ASIC chip, makingits functions more complex (high complexity receiver). In this case, thesilicon area of the transmitter will be much smaller than thecorresponding receiver. The same strategy is applied to a pair of ASICchips having high complexity transmitter and a low complexitycorresponding receiver. The strategy also applies to a pair of highcomplexity and low complexity transceivers (combinedtransmitter/receiver). For example, in some embodiments, on one side,there is a low-complexity transceiver, and on the other side, there canbe corresponding high complexity transceiver.

In some embodiments, Turbo encoding is performed on the patch-ASIC chip,while turbo decoding is performed on the base-ASIC chip. Typically, aturbo encoder complexity is exceedingly low compared to that of a turbodecoder. A turbo encoder typically encodes a data stream using two ormore block or convolutional encoders, and transmitting the coded bits ina multiplexed fashion. One of the encoders encodes the data streamdirectly, while the other encoders first interleave the data streambefore encoding it. The encoded bit streams are sometimes punctured bythrowing away certain bits before being multiplexed and transmitted.This is done to meet channel data rate and bandwidth requirements.

The turbo decoder on the base-ASIC chip performs the inverse function ofa turbo encoder by decoding the received data stream to recover theoriginal data stream that is encoded on the transmit side. In theprocess of decoding, the decoder is able to correct errors introduceddue to poor channel quality (fading, noise and interference) duringtransmission. The turbo decoder usually operates on soft-decisionreceived bits, and iteratively decodes the coded bits from each of theencoders, while feeding channel quality information from one decoder(corresponding to one encoder) to the other decoder (corresponding tothe other encoder). The turbo decoder typically uses a MAP (maximum aposteriori) algorithm as part of the decoding process. At eachsuccessive iteration, the additional channel quality information fromone decoder helps decode the encoded stream with the other decoder in amore reliable fashion. At the end of a few iterations when high-level ofreliability is achieved, hard-decision bits corresponding to theoriginal data stream (input to the encoders on the transmit side) arerecovered. In the process of decoding, the turbo decoder performsseveral stages of de-interleaving and re-interleaving of the receivedand recovered data streams. Turbo encoding and decoding is described inC. Berrou, A. Glaviex, and P. Thitimajshima, IEEE Int. Conf. Commun.,vol. 2, Geneva, Switzerland, May 1993, pp. 1064-1070, and B. Vucetic, J.Yuan, Kluwer Academic Publishers, 2000.

One aspect of the invention is a system comprising a base-ASIC chip anda patch-ASIC chip designed to work together wherein the base-ASIC chiphas more silicon area than the patch-ASIC chip. The silicon area of thebase-ASIC chip is larger, in general, because the base-ASIC chip hasmore processing capability as described herein. In some cases the highersilicon area of the base-ASIC chip is due, in large part, to the higheramount of processing resources for the radio core on the base-ASIC chip.In some embodiments, the ratio of the area of the base-ASIC chip to thearea of the patch-ASIC chip is greater than about 1.5. In someembodiments, the ratio of the area of the base-ASIC chip to the area ofthe patch-ASIC chip is greater than about 2. In some embodiments, theratio of the area of the base-ASIC chip to the area of the patch-ASICchip is greater than about 3. In some embodiments, the ratio of the areaof the base-ASIC chip to the area of the patch-ASIC chip is greater thanabout 4. In some embodiments, the ratio of the area of the base-ASICchip to the area of the patch-ASIC chip greater than about 5. In someembodiments, the ratio of the area of the base-ASIC chip to the area ofthe patch-ASIC chip greater than about 10. In some embodiments, theratio of the area of the base-ASIC chip to the area of the patch-ASICchip is greater than about 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 20, orgreater than 20. In some embodiments the ratio of the area of thebase-ASIC chip to the area of the patch-ASIC chip is in a range of about1.5 to about 3. In some embodiments the ratio of the area of thebase-ASIC chip to the area of the patch-ASIC chip is in a range of about2 to about 3. In some embodiments the ratio of the area of the base-ASICchip to the area of the patch-ASIC chip is in a range of about 2 toabout 5. In some embodiments the ratio of the area of the base-ASIC chipto the area of the patch-ASIC chip is in a range of about 3 to about 8.In some embodiments the ratio of the area of the base-ASIC chip to thearea of the patch-ASIC chip is in a range of about 4 to about 8.

The absolute area of the silicon will depend, for example, on the typeof processing which is used. For example, for 0.13 micron CMOSprocessing, the patch-ASIC chip can have a silicon area of, e.g. of 2mm², 4 mm², or 9 mm², while the base-ASIC chip can have a silicon areaof, e.g. 4 mm², 9 mm², or 16 mm².

The silicon area can be readily measured by measuring the geometric (twodimensional) area of the ASIC chip. For a rectangular chip, the area canbe calculated by multiplying the length of the height and width (not thedepth) of the chip. For a chip with irregular dimensions, the area canbe easily be determined by one of skill in the art.

One aspect of the invention is a method comprising a base-ASIC chip anda patch-ASIC chip designed to work together wherein the base-ASIC chipdissipates more power than the patch-ASIC chip. An aspect of theinvention is a method comprising: monitoring a physiological conditionusing two or more ASIC chips and a host device wherein the chips aredesigned to work together to measure physiological signals comprising:(a) receiving signals from a sensor at a patch-ASIC chip that isincorporated into a physiological signal monitoring patch, thepatch-ASIC chip comprising a sensor interface coupled to the sensor, aprocessor coupled to the sensor interface, a memory element coupled tothe processor, a radio coupled to the memory element; (b) transmittingdata signals from the radio on the patch-ASIC chip through an antennaincorporated into the patch; (c) receiving the data signals at abase-ASIC chip comprising an antenna that sends the signals to aprocessor that processes data signals, a memory element coupled to theprocessor, a radio coupled to the memory element, and a host interfacethrough which the base-ASIC chip communicates with a host device; and(d) transmitting instructions wirelessly from the base-ASIC chip to thepatch-ASIC chip; wherein the base-ASIC chip consumes more power than thepatch-ASIC chip. Power is energy transferred per unit time. Power is aninstantaneous value, while Energy relates to the amount of power usedover time. Thus, when the power dissipated by a chip of the presentinvention, the power dissipation is generally measured over a period oftime, in which case, for example, the average power over that timeperiod can be determined. When calculated in this way, the ratio ofaverage power over time or the ratio of energy dissipated can be used.The power dissipation of the base-ASIC chip is larger, in general,because the base-ASIC chip has more processing capability as describedherein.

In some cases the higher power dissipation of the base-ASIC chip is due,in large part, to the higher amount of processing resources for theradio core on the base-ASIC chip. In some embodiments, the ratio of thepower dissipation of the base-ASIC chip to the power dissipation of thepatch-ASIC chip is greater than about 1.5. In some embodiments, theratio of the power dissipation of the base-ASIC chip to the powerdissipation of the patch-ASIC chip is greater than about 2. In someembodiments, the ratio of the power dissipation of the base-ASIC chip tothe power dissipation of the patch-ASIC chip is greater than about 3. Insome embodiments, the ratio of the power dissipation of the base-ASICchip to the power dissipation of the patch-ASIC chip is greater thanabout 4. In some embodiments, the ratio of the power dissipation of thebase-ASIC chip to the power dissipation of the patch-ASIC chip greaterthan about 5. In some embodiments, the ratio of the power dissipation ofthe base-ASIC chip to the power dissipation of the patch-ASIC chipgreater than about 10. In some embodiments, the ratio of the powerdissipation of the base-ASIC chip to the power dissipation of thepatch-ASIC chip is greater than about 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15,20, or greater than 20. In some embodiments the ratio of the powerdissipation of the base-ASIC chip to the power dissipation of thepatch-ASIC chip is in a range of about 1.5 to about 3. In someembodiments the ratio of the power dissipation of the base-ASIC chip tothe power dissipation of the patch-ASIC chip is in a range of about 2 toabout 3. In some embodiments the ratio of the power dissipation of thebase-ASIC chip to the power dissipation of the patch-ASIC chip is in arange of about 2 to about 5. In some embodiments the ratio of the powerdissipation of the base-ASIC chip to the power dissipation of thepatch-ASIC chip is in a range of about 3 to about 8. In some embodimentsthe ratio of the power dissipation of the base-ASIC chip to the powerdissipation of the patch-ASIC chip is in a range of about 4 to about 8.The ratios are generally measured when the patch-ASIC chip and base-ASICchip are in communication. In some embodiments the ratios are measuredwhile the patch-ASIC chip and base-ASIC chip are in continual datatransmission.

The absolute amount of power dissipated or energy used will dependheavily on the type of process used and the implementation of the radiosystem. In an implementation in CMOS process where two radios arecooperating (a UWB radio and a narrowband radio), for example, thepatch-ASIC chip can dissipate about 1 mW, 4 mW, or 10 mW of power andthe base-ASIC chip can dissipate about 2 mW, 8 mW, or 20 mW of power.

The measurement of the amount of power dissipated or energy used isunderstood by those of ordinary skill in the art. It is understood thatunder normal operation, the ASIC chips are not using power at a constantlevel. As used herein, the power dissipation is generally measured whilethe radio is being used, that is, while the patch-ASIC chip andbase-ASIC chip are in communication. The power numbers are generallymentioned for continual data transmission from the patch-ASIC chip tobase-ASIC chip. The patch-ASIC chip power numbers include the powerdissipation in the following circuits: capturing the data from thesensors, preprocessing of data to make it suitable for radiotransmission, radio, and driving the antenna. The reverse order appliesfor the base-ASIC chip power. As used herein, the “continual datatransmission” can be, for example, the patch-ASIC chip continuallytransmitting data from the sensors attached to it to the correspondingbase-ASIC chip with the following conditions: (i) The source data rateof the sensor being of the order of 100 Kbits/sec, (ii) the wirelesslink reliability being very high in a typical indoor environment wherehealthcare systems are deployed (link reliability about 99.99%), and(iii) little to no loss of sensor data The continual transmission timecan range from a few seconds to many days. For example, the transmissiontime can be about 2, 5 10, 30 or 60 seconds, or, 2, 5, 10, 30, or 60minutes, or 2, 3, 6, 12, or 24 hours, or 2, 5, 10, 20, 30, 60 or 90days.

In one aspect, the system includes a medical signal processor whichcommunicates with a wireless distributed sensor system as its peripheralfor detecting physiological parameters of the person and for providingsignals indicative thereof. The term μ-Base as used herein isinterchangeable with medical signal processor or MSP. In one embodiment,the medical signal processor wirelessly receives the signals from thedistributed wireless sensor system in a multiplexed fashion andprocesses the signals to provide an indication of the health of theperson. The indication of health could relate to a disease state,general health or fitness level of a person. In some embodiments, thesystem includes a mobile device for receiving the indication of thehealth of the person to allow for a diagnosis or treatment of theperson, and a secure server for securely storing the at least oneindication of health. The core processing resources of the medicalsignal processor, for example the μ-Base allows wireless distributedsensors to be ultra reliable/secure, ultra low power, ultra small andlow cost. The peripheral wireless sensors can be a within a reasonablerange of medical signal processor such as the base-ASIC chip. In someembodiments, the sensors are within 1 to 3 meters for example next to abed in a hospital room. In some embodiments, the sensors are within 1 to10 meters for example within a room. In some embodiments, the sensorsare within 1 to 30 meters for example within a typical home.

A distributed sensor based mobile/remote monitoring system for themanagement of various types of diseases is disclosed. The system iscapable of continuously monitoring a variety of parameters relating tothe state of various diseases. The parameter monitoring can becontinuous, periodic or episodic. The system is capable of continuousmonitoring of given parameters from a few seconds to many days. A systemto manage a particular type of disease or meet a health objective can bedefined by selecting the appropriate parameters for that disease. Forexample, an ECG can be monitored on a patient in order to diagnose andprescribe treatments for cardiac care.

The present invention relates generally to health monitoring and moreparticularly to a health monitoring system that utilizes a medicalsignal processor or μ-Base with a wireless distributed sensor system.The following description is presented to enable one of ordinary skillin the art to make and use the invention and is provided in the contextof a patent application and its requirements. Various modifications tothe preferred embodiments and the generic principles and featuresdescribed herein will be readily apparent to those skilled in the art.Thus, the present invention is not intended to be limited to theembodiments shown, but is to be accorded the widest scope consistentwith the principles and features described herein.

To describe the feature of the medical signal processing system in moredetail, refer now to the following description in conjunction with theaccompanying figures.

FIG. 1A is an embodiment of a general architecture of a wireless medicalsignal processing system 100 in accordance with the present invention.

The system 100 is centered around a medical signal processor 104, suchas a μ-Base that has a wireless distributed sensor network as itsperipheral. The distributed sensor network includes a plurality ofpatches 102 a-102 n on a person 101. The patches 102 a-102 n can beinternal to the body, coupled to the exterior of the body embedded inthe garments or can be in close proximity of the body by some othermeans. In some embodiments, the patches comprise a μ-Patch and apatch-ASIC chip. The patches communicate wirelessly with MSP 104. Insome embodiments, MSP 104 also includes its internal/local sensors 106,which can engage the body of the person, which are also part of thedistributed sensor system. The medical signal processor (MSP) 104 inturn communicates with a mobile device 108. The mobile device 108 inturn communicates with a secure server 110 via a wireless or wirednetwork. In this embodiment, the MSP 104 is a separate component fromthe mobile device 108. However, one of ordinary skill in the art readilyrecognizes that the MSP 104 could be incorporated into the mobile deviceas shown in FIG. 1B which is a second embodiment of the system 100. TheMSP 104 also includes sensors 106, which can engage the body of theperson, which are also part of the distributed sensor network. The MSP104 has the ability to absorb significant processing burden from all ofits distributed sensors to form a reliable wireless link with them. TheMSP 104 also has the ability to communicate with all of its distributedsensors through a wireless uplink. It allows the MSP 104 to use itsinternal resources to monitor, control and dictate various performancefactors of the distributed sensors to achieve the performance balanceneeded for any given application. The MSP 104 also can perform varioushouse keeping functions for the overall medical signal processingsystem.

The mobile device 108 could be, for example, a cellular telephone,laptop, notebook, a smart phone, a PDA, a custom medical device or anystationary, portable, or mobile device which can communicate with theserver over a network. Each component of the health monitoring system100 will now be described in detail in conjunction with the accompanyingfigures.

Medical Signal Processing System

As discussed above, the medical signal processing system as shown inFIGS. 1A and 1B can include a variety of sensors—either directlyintegrated in the medical signal processor or μ-Base 104, or linked tothe medical signal processor 104 via a wireless link as patches 102 onthe body of a user. Examples of various sensors that can be included inthe distributed sensor system are shown in FIG. 2. Out of theseexamples, certain sensors can be chosen for implementation as patches102, comprising, for example a patch-ASIC chip. Other sensors can bechosen for integration within the MSP 104. In this way, a variety ofsystems can be designed for the management of diseases, health andfitness, by choosing the sensors that monitor the appropriate parametersassociated with target applications.

Modes of Operation: By using the distributed sensor network, the systemof FIGS. 1A and 1B can monitor parameters in different ways. Forexample, by wearing patches on the body, the monitoring and/ortransmission can be done continuously—e.g. continuously sensor dataflowing from sensors in to the mobile device to the secure server.Patches can also be used for periodic or episodic monitoring. In someembodiments, the monitoring is done continuously, but the transmissionis done in bursts. This is accomplished by using memory within thepatch-ASIC chip to buffer data by storing the data for latertransmission. In some embodiments, the data is stored in memory, andthen regularly transmitted in bursts, for example, every second, every10 seconds, every minute, every 2 minutes, every 5 minutes, every 10minutes, or every 30 minutes. By transmitting in this regular burstmode, the patch can save energy over transmitting continuously becausetransmitting takes energy, and spending less time transmitting savesenergy. The data transmitted in bursts is generally transmitted at ahigher rate than the rate of sampling. In some embodiments, the data isstored in a buffer during a time period during which the patient wearingthe patch is farther away from the μ-Base. This embodiment allows forenergy to be conserved in the patch in the present invention due to theability of the μ-Base to control the transmission mode of the patch. Forexample, the μ-Base can control the power at which the patch transmitsdata or the mode of transmission. The μ-Base can instruct the patch tostore incoming data while the patch is farther away when it would takehigher power and more energy to transmit, and later instruct the patchto send the data at lower power when the patch is closer to the μ-Base.

In some cases, the system is used in stand-alone mode. In a stand-alonemode, monitoring is normally done in an episodic or periodic mode byusing the MSP 104 and sensors 106. For example, a cardiac rhythm can bedirectly monitored by pressing the MSP 104 against the body by using abuilt in ECG sensor. Another example of this stand-alone mode isglucose, cholesterol or blood coagulation monitoring. A drop of bloodcan be placed on a biochemical sensor that is built into the MSP 104which can be converted to electrical signal by MSP for furtherprocessing. The glucose, cholesterol or blood coagulation rate readingwill be registered in the sensor database on MSP 104 and/or mobiledevice 108 and/or the secure server 108.

Wearable Wireless Patches 102

Patches 102 are integrated circuit technology driven miniature wirelessdevices that can be conveniently attached to the body. Patches can alsobe designed for implanting within the body of a person. To achievecompactness, the patches 102 can be designed using a custom ASIC (apatch-ASIC chip) and a compact multi-chip module. The patches can befurther simplified by leveraging the resources of MSP 104. The patch 102in a preferred embodiment has two main parts: sensor circuits, and aradio core for the transmission of sensor data to other devices. Inaddition, it has a signal processor and power management circuits toachieve very low power dissipation. The sensor circuits can be directlyincorporated in the custom ASIC and/or patch can also include astandalone sensor device whose data can be transmitted to other devicesusing the radio or ASIC on the patch. In a preferred embodiment, aperson can wear a patch 102 for several days for continuous monitoringwithout changing or recharging the power source. Patches 102 can havethe ability to receive wireless signals from the MSP 104 μ-Base toenhance its own power dissipation and improve its own wireless linkreliability, based on the MSP's 104 monitoring of radio environment andapplication requirements. The patches 102 can also receive test/controlsignals from the MSP 104 to get authenticated and to check its ownfunctionality.

FIG. 3 illustrates a wireless patch 102 utilized in accordance with thepresent invention. The wireless patch 102 receives signals from a bodysensor 202 via a sensor interface 204. The patch 102 may receive signalsfrom a body it is either in contact with, or in close proximity of. Thesensor interface 204 can receive electrical signals or other signalsrepresentative of different physiological parameters of the body. Theoutput from the sensor interface 204 is provided to a processor 208which processes the signal to perform various functions such ascompression to reduce the data rate, encoding to achieve highreliability and manage buffering to vary duty cycle of radio. Theprocessed data is presented to a storage element 214. The data from thestorage element 214 is provided to a radio 210 which outputs the signalto a signal antenna 212. The storage element 214 can be adapted to becoupled to a local display/alert 216. A power source 209 provides powerand power management to all elements of the patch 102. As shown, awireless path through radio/antenna 210/212 also exists to receive testand control signals from the MSP 104 as discussed above. As shown, allresources of the patch 102 can be controlled by the MSP 104 by a signalC, wirelessly coming to patch 102 from the MSP 104.

Accordingly, by leveraging the information sent by MSP 104 via signal C,patches can dynamically alter the performance of their variousfunctional blocks to choose trade off among high reliability, highsecurity, low power and low cost for given applications of healthmonitoring.

FIG. 3A illustrates another embodiment of a wireless patch comprising aμ-Patch and a patch-ASIC. The wireless patch 102 comprises a patch—ASIC120 which receives signals from either external analog sensors 220 orbuilt in sensors 221 via a sensor interface 204 which has an analog todigital converter (ADC). The patch-ASIC 120 can also receive signalsfrom digital sensors 222 that can that can be sent via the a sensor busto the processor without passing through the sensor interface 204. Thesensor interface 204 can receive electrical signals or other signalsrepresentative of different physiological parameters of the body. Theoutput from the sensor interface 204 is provided to a processor 208which processes the signal to perform various functions such ascompression to reduce the data rate, encoding to achieve highreliability and manage buffering to vary duty cycle of radio. Theprocessed data is presented to a storage element 214. The data from thestorage element 214 is provided to a radio 210 via radio interface 207which outputs the signal to a signal antenna 212. The processor 208 canbe adapted to be coupled to a local display/alert 216. A powermanagement circuit 209 connects to the processor 208 and exerts controlover the elements of the patch to control the power that is supplied bya battery external to the μPatch. A wireless path through radiointerface 207, radio 210 and antenna 212 also exists to send data to theμ-Base (MSP) 104 and to receive test and control signals from the μ-Base(MSP) 104 as discussed above. Here, the antenna 212 resides outside ofthe patch-ASIC 120 and is attached to a PCB on the μ-Patch along withthe patch-ASIC. As shown, all resources of the patch 102 can becontrolled by the MSP 104 by a signals received through the antenna. Thepatch-ASIC 120 can also have an encryption processor 225 having an AES,CRC, and/or FEC coprocessors connected to the processor 208 for signalencoding and/or decoding. In some embodiments the encryption processoron the patch-ASIC has only circuits for encoding but not decodingcircuits.

In summary, the trade off is possible due to any of or any combinationof the following features:

a. A sensor interface to connect to a variety of physiological sensors

b. A radio subsystem that can support a variety of communication schemes(e.g. different modulations including analog modulation, variouscodings, various data rates) to wirelessly communicate with a medicalsignal processor which is within a reasonable range, such as within atypical house

c. A processor to support a variety of wireless communication schemesfor radio system

d. A processor that can implement various authentication and securityschemes as desired by application

e. Means to wirelessly receive a variety of test signals from a medicalsignal processor

f. Means to run test signal though its data paths and generate outputsignals in response

g. Means to wirelessly send resulting output signals back to medicalsignal processor

h. Means to receive various control signals to reconfigure its variousfunctional blocks

i. Reconfigurable internal blocks to alter data rates, radio scheme,communication algorithm, power dissipation levels, etc.

j. sensors that can receive body's electrical physiological signals

k. Encapsulation in a packaging material that can also provide a bodyinterface

l. Using its radio, generation of a RF beam that can be directed towardsa part of person's body to probe internal parts

m. Means to receive the RF signals scattered by body that can beanalyzed to get information about the internals of the body

n. Means to bring the device in a close proximity of body

o. Means to attach the device to body

p. Means to analyze and display the sensor data

q. Means to alert a person as needed

r. For ultra high reliability, ability of patches to wirelesslycommunicate with each other in case of loss of link by a patch tomedical signal processor

Medical Signal Processor (MSP) 104 (μ-Base)

The medical signal processor (MSP) 104 collects and receives data fromthe one or more of the distributed sensors (internal or external), andaggregates and processes this data. In addition, the MSP 104 canreliably transmit it to mobile device 100 in such a way that mobiledevice 100 in turn can transmit the data to a remote server system overwireless, cellular, or any type of wide area network (WAN).

The MSP 104 may have one or more of the following features:

1. to collect data from its internal/local sensors

2. radio/processors to receive data from external wireless sensors thatare within a reasonable range, such as within a typical house

3. means to process and aggregate the sensor data based on an algorithmthat can be programmed in MSP 104 to determine a diseases state and/orhealth state and/or fitness state

4. means to attach or connect or plug in to a mobile device

5. means to generate an alert based on the determination of the state ofdisease, health or fitness

6. means to locally display collected raw sensor data or processed data

7. means for transmission of collected raw sensor data or processed datato a remote server either directly or via a mobile device

8. means to enable continuous reliable transmission of sensor data overa cellular or wide area network

9. user interface to control the operation of monitoring system

10. means of a regular cell phone device (voice, data and imagecommunication, display, keypad, etc.)

In addition to collecting and processing the data from all of itsperipheral patches/sensors, the MSP 104 also has various means towirelessly monitor and control all of its peripheral patches/sensorsthrough a wireless uplink with them. Essentially, the MSP 104 becomes anintegral part of the wireless medical signal processing system toachieve the overall requirements of the system—a major requirement beingpatches to be ultra reliable/secure, ultra low power, ultra small andlow cost. The overall functionality of the system is asymmetricallypartitioned between the patches 102 and MSP 104 to achieve thesecritical patch requirements.

Accordingly, MSP 104 may have the following features to achieve thesystem objectives:

1. means to act as a master of the overall system and patches/sensors tobe its slaves

2. means to manage a distributed network of patches/sensors

3. means to authenticate, test and control the functionality of all ofits peripheral patches/sensors

4. means to monitor/dictate the wireless link performance of itsperipheral patches/sensors

5. means to monitor/dictate the power dissipation of its peripheralpatches/sensors

6. means to dictate the degree of reliability of all of its peripheralsensors/patches

7. means to allow peripheral sensors/patches to use a very simple radioand have its own signal processor to complete the radio processing forpatches/sensors

8. means to recreate the original sensor data if data has beencompressed on the sensor/patches

9. means to monitor radio environment.

10. Radio to work with multiple communication schemes including digitaland analog modulation

The MSP (μ-Base) 104 can control the functionality and performance ofits peripheral/patches based on the requirement defined for the overallsystem. The system performance can be dynamically adjusted, for example,due to a change in radio environment or a change in person's conditionas monitored by the MSP 104.

FIG. 4 illustrates an MSP (μ-Base) 104 in accordance with the presentinvention. An antenna 301 and a radio 302 within the MSP 104 receives aplurality of data signals (signals A-N) from the distributed sensornetwork. The radio 302 then provides these signals to a signal processor304. The processor 304 then decodes the signals received by the radio302. The decoded signals are then provided to a smart signal combiner306, in a multiplexed or parallel fashion.

The smart signal combiner 306 includes a means for programming analgorithm for combining the signals to provide an indication of a stateof the body. For example, certain sensor parameters taken together mightindicate a disease state and/or heath state and/or fitness state of anindividual.

The smart signal combiner 306 may also receive a signal Y from the localsensors 106 in the MSP 104. The signal Y represents either one signalfrom one local sensor or a plurality of signals from a plurality oflocal sensors. The smart signal combiner 306 also provides a signal (X)that is a parameter, relating to a state that has been measuredutilizing a single sensor output or by combining the outputs of multiplesensors. This state is a result of one or several physiologicalparameters of the body and the signal X may be a function, computed overtime, of one, all or a set of those sensor outputs (signals A-N) andsensor signals.

These various signals (A, B, . . . N, Y, X) are provided to a storageelement 308 by the smart signal combiner 306. The storage element 308may be any type of memory that can be utilized in integrated circuits.The storage element 308 can be adapted to be coupled to a localdisplay/alert device 311 via the sensor interface 313. The data can thenbe retrieved by the mobile device from the storage element 308 via a businterface 310. As before mentioned, the MSP 104 can either be part ofthe mobile device 108 or a stand alone device.

All these resources enable MSP 104 to act as a stand-alone device toprovide the needed information locally to concerned parties or it cantransmit the information to a remote secure server for furtherprocessing and access. The information can be used locally, or remotely,to diagnose/treat a disease or for general health/fitness management ofa person. As shown, MSP 104 also has a wireless path to communicate withpatches/sensors to monitor and control their performance. In a controlmode, radio 302 operates in an uplink mode by sending test/control datavia signal P over the wireless link. This control mode is activated whenthe MSP 104 needs to test, monitor and/or control its peripheralpatches/sensors via the processor 304. The processor 304 should be forexample, a microprocessor with signal processing capability thatexecutes the various functions.

The processor 304 can utilize other resources such as smart signalprocessor 306 and storage 308 to carry out its control/test related andgeneral processing tasks. In the control mode, for example, theprocessor 304 can generate test signals and send to a patch 102, andanalyze the signals received from the patch 102 to estimate its wirelesslink performance. If needed, the MSP 104 can then send control signalsto alter the wireless link performance by changing certain parametersrelating to radio functions of the patch 102, for example by instructingsignal processor 208 and radio 210. In some implementations, some of theinternal blocks of MSP 104, such as processor 304, smart signalprocessor 306 and storage 308 can be implemented in software. Thisimplementation is likely when MSP 104 functionality is embodied within amobile device, computer, a custom medical device, or any other device.

FIG. 4A illustrates another embodiment of an MSP (μ-Base) 104 of thepresent invention. The μ-Base 104 comprises a base-ASIC 130. An antenna301 is connected to the base-ASIC 130 through a PCB to which thebase-ASIC 130 and antenna 301 are also attached. The antenna sendssignals to the radio 302 that it receives data from the patch 102. Theradio 302 then provides these signals to a signal processor 304 throughradio interface 307. The processor 304 then decodes and can furtherprocess the signals received by the radio 302. The processor can sendthe data to storage element 308. The data can then be retrieved fromstorage element 308 and sent to a host device 150 (which could, forexample, be a mobile device 108) through the host interface 310. Asshown, MSP 104 also has a wireless path to transmit to withpatches/sensors to monitor and control their performance. In a controlmode, radio 302 operates in an uplink mode by sending test/control dataover the wireless link. This control mode is activated for the MSP 104to test, monitor and/or control its peripheral patches/sensors/gates viathe processor 304. The processor 304 should be for example, amicroprocessor with signal processing capability that executes thevarious functions. In the control mode, for example, the processor 304can generate test signals and send to a patch 102, and analyze thesignals received from the patch 102 to estimate its wireless linkperformance. If needed, the MSP 104 can then send control signals toalter the wireless link performance by changing certain parametersrelating to radio functions of the patch 102, for example by instructingsignal processor 208 and radio 210. The base-ASIC 130 also has thecapability of receiving signals from external analog sensors 320 orlocal analog sensors 321 to processor 304 through sensor interface 313.The base-ASIC can also receive signals from digital external sensors 322to the processor 304. The base-ASIC 130 can also have an encryptionprocessor 325 having for example AES. CRC, and/or FEC coprocessorsconnected to the processor 208 for signal encoding and/or decoding. Inaddition, as shown, the processor 304 is connected to a digital signalprocessing chip (DSP) 326 through a coprocessor bus for performing smartantenna protocols such as beam-forming or for processor intensivedecoding algorithms. A power management circuit 309 connects to theprocessor 304 and exerts control over the elements of the patch tocontrol the power that is supplied by a power supply external to theMSP.

The functionality of MSP 104 allows its distributed sensors (patches) tomaintain high wireless reliability, high security, low power and lowcost. Furthermore, the versatility of MSP 104 allows it to create avariety of different types of medical systems. To allow thisfunctionality and versatility, in summary, it can include any of or anycombination of the following features:

a. Means to wirelessly communicate with a plurality of peripheralwireless physiological sensors in a multiplexed fashion that are withina reasonable range, such as within a typical house

b. Means to manage a network of plurality of said sensors as theirmaster

c. Means to display health state information or the data received fromperipheral sensors

d. Means to alert a person about health state

e. Means to connect to a mobile device to exchange information with itand to communicate with a remote server through mobile device'sconnectivity to a wide area network

f. Partitioning of its functions between hardware and software to allowits integration within a mobile device

g. Means to wirelessly send a variety of test signals to its peripheralsensors and analyze the received signals to monitor the properfunctioning of the sensors and their various internal functional blocks

h. Means to send various control signals to peripheral sensors toconfigure their various functional blocks:

i. Means to monitor peripheral sensors to determine their respectivepower dissipation rates and the state of their power sources; tosupervise power management

j. Means to monitor surrounding radio environment to determine anoptimum wireless communication scheme at any given instance

k. Means to instruct peripheral sensors to utilize a particularradio/communication mode for reliable operation

l. Means to authenticate peripheral sensors

m. Means to monitor various security aspects of peripheral sensors

n. Means to allow coupling to local sensors through a wired connection

o. A processor to support the execution of a variety of communicationalgorithms/schemes to allow peripheral sensor to use the simplestpossible communication scheme for a given application to minimizesensor's power and resource requirements by absorbing the burden ofprocessing (asymmetric communication scheme)

p. A smart signal combiner that can be programmed to run neededalgorithms to (i) analyze signals from one or more peripheral sensorsover time, and/or (ii) combine signals from a plurality of peripheralsensors; to determine a health state

q. Storage media to store the health state information and/or raw datareceived from peripheral sensors

Mobile Device 108

The mobile device 108 could be, for example, a cellular telephone,laptop, notebook, a smart phone, a PDA, a custom medical device or anymobile device which can communicate with the server over a wide areanetwork and/or Internet. The mobile device 108 can also be a regularcell phone handset, which has been modified to include the appropriatefeatures and means to work with MSP 104. The mobile device 108communicates with the MSP 104. In one embodiment, the MSP can be builtwithin mobile device 108 as part of the mobile device design. In thismode, many internal functions of MSP can be implemented in software. Inmost cases, MSP's radio system and sensor interfaces will remain intactin hardware.

Secure Server 110

The secure server 110 receives data from distributed sensors over acellular telephony network, any type of wide area network or Internetvia MSP 104 and the mobile device 108. The server 110 further processesthe received data from the mobile device and stores it in a securelocation. The server 110 may also contain various types of softwareprograms, including software to manage health information databases(such as electronic medical records, computerized purchase orders andcomputerized prescription systems). The secure server 110 may also havethe middleware to process/link sensor data to such health informationdatabases.

The data stored on the secure server 110 may be accessed by a healthcareprovider, caregiver or patient via the Internet by using any type ofterminal device such as computer, mobile device, cell phone, smart phoneor personal data assistant (PDA).

The health monitoring system in accordance with the present inventionsupports many classes of sensors for physiological data collection, suchas:

1. The health monitoring system supports many classes of sensors forphysiological data collection, such as:

-   -   a. Sensors (either patches 102 or sensors 106) contacting the        body 101 through gels, etc.    -   b. Patches 102 embedded within the body 101 through surgical        procedures.    -   c. Patches 102 probing the body 101 through micro-needle based        skin punctures.    -   d. Sensors in close proximity of the body 101 -e.g., probing        using a microwave or optical beam.    -   e. Sensors embedded in the MSP 104 or mobile device 108 for        periodic or occasional use.    -   f. Sensors that can read biochemical micro-fluidic test strips        (e.g. glucose, blood coagulation rate) via electrical or optical        sensor

2. The health monitoring system in accordance with the present inventioncan support one of these sensors and/or patches or multiple sensorsand/or patches from multiple classes.

3. The MSP 104 has the ability to collect data in real time from manysuch sensors and/or patches and to apply a chosen algorithm to combinesignals from various sensors and/or patches to determine or predict aphysiological or disease state.

4. The MSP 104 can store data for local use and/or transmit in real timeto a remote server for use by clinicians and other parties. If desired,some of the MSP 104 functions can be implemented on a remote sensor.

5. As stated above, one function of the MSP 104 is physiological dataprocessing.

6. The second function of MSP 104 is to manage all patches and/orsensors for optimal functionality—managing authentication/securityfunctions, monitor and enhance the radio transmission performance ofpatches and/or sensors to increase link reliability, monitor andminimize power dissipation by patches and/or sensors.

The health monitoring system in accordance with the present inventioncan be utilized in a variety of environments. One example is the cardiacdisease management system. To describe the features of such a systemrefer now to the following description in conjunction with theaccompanying figures.

A Mobile/Remote Monitoring System for Cardiac Disease Management

An embodiment of a cardiac disease care product in accordance with thepresent invention is described herein below. FIG. 5 is a block diagramof a cardiac care product in accordance with the present invention. Thecardiac care product includes a mobile device 504 which utilizes patches102″ and biostrips as sensors 510. The mobile device 504 includes an ECGevent recorder 502, a geographic positioning system (GPS) and healthutilities. The patches may include a Holter mechanism and a loop ECGmonitor 506 as well as accelerometers for detecting physical activity.The biostrips 510, which are basically microfluidic test strips, may beutilized, for example, for anticoagulation analysis of the blood(PT/INR).

FIG. 6 is a block diagram of one implementation of a mobile deviceutilized with the cardiac care product of FIG. 5. The mobile device 504may receive a first SD (Secure Digital) card 602 that includes wirelessreal-time monitoring system. The SD card 602 receives data from patches102″″ and other sensors. The mobile device 504 also may receive a secondSD card 604 that monitors PT/INR, glucose and the like. The second SDcard receives its data via biostrips 606 that can be activated by a dropof patient's blood, for example. The PT/INR and/or glucose reading isobtained by building an electrical or optical reader on the second SDcard that can read the biostrips. The cardiac care product can be usedfor the management of various cardiac diseases, including arrhythmia. Inan embodiment, this cardiac care product monitors the followingparameters:

1. ECG signals (time duration programmable—few seconds to few weeks)

2. Pulse and respiration

3. Patient's physical movement

4. Blood coagulation analysis for drug therapy for the treatment ofarrhythmia

5. A mobile, integrated system for remote cardiac care is provided—It isa system that is useful for diagnosis and treatment of various cardiacdiseases.

6. Its core functions are listed below:

-   -   a. Wireless AECG—duration programmable from a few seconds to 30        days to serve a variety of functions including Holter        monitoring, cardiac event monitoring, cardiac loop monitoring        (wireless ECG sensor patches and receiver)    -   b. PT/INR based blood anticoagulation analysis (dry chemistry        microfluidic strip and optical/electrical reader/sensor)

7. Its auxiliary functions are listed below:

-   -   a. Patient activity recording (accelerometer sensor)    -   b. Patient location information (GPS)    -   c. Ability to connect to an implanted wireless pacemaker    -   d. Medication schedules (software)    -   e. Doctor visit and treatment schedule (software)

8. Microfluidic biostrip/reader concept can also be used for glucosemonitoring

9. The system can be built by integrating the electronics inside amobile device/computer or an attachment to a mobile device/computer. Themobile device 504 may or may not be connected to a remote server througha network.

The sensors for parameter monitoring may be distributed between thepatches 102″″ and the mobile device 504 as follows:

Patches 102

The patches 102″″ have sensors to continuously monitor ECG, pulse,respiration and patient's physical movement. ECG function can beprogrammed to work in any mode as prescribed by a physician, such as:

a. Continuous ECG: for any amount of time (e.g. 24 Hrs, 48 Hrs, sevendays, thirty days).

b. ECG Loop recorder: Shorter time recordings with continuousoverwriting

Patient's physical movement data is recorded along with ECG data on acontinuous basis. In addition, pulse and respiration are recorded asdesired.

MSP 104

In a stand-alone mode, the mobile device 504 has the means to monitor afew different parameters as below:

a. ECG Event Recording: Via built-in ECG sensor, mobile device 504 isable to record ECG signals for any duration as desired. In this mode,the mobile device 504 is directly held to the body 101.

b. Biochemical parameters: The mobile device 504 has a built inbiochemical sensor, electrical sensor and an optical sensor. Any ofthese sensors can be used to read certain parameters relating to diseasemanagement. For example, the MSP 104 can register blood coagulationreadings for PT/INR (Prothrombin Time/International Test Ratio) analysisfor Warfarin drug therapy. For this application, a test strip with ablood drop mixed with a chemical reagent can be inserted into the MSP104 to determine blood anticoagulation rate for PT/INR analysis.

A distributed sensor based mobile/remote monitoring system for themanagement of various types of diseases is disclosed. The system iscapable of continuously monitoring a variety of parameters relating tothe state of various diseases. The parameter monitoring can becontinuous, periodic or episodic. Some of the parameters that can bemonitored by the system are ECG (electrocardiograph), EEG(electroencephalograph), EMG (Electromyography), blood glucose, pulse,respiration, blood pressure, temperature, SpO₂, body fluid density,blood density, patient physical movement and patient physical location.A system to manage a particular type of disease can be defined byselecting the appropriate parameters for that disease. The system can beapplied to manage many type of diseases and conditions, suchas—arrhythmia, heart failure, coronary heart disease, diabetes, sleepapnea, seizures, asthma, COPD (Chronic Obstructive Pulmonary Disease),pregnancy complications, wound state, etc.

An innovative technology base is needed to address wide rangingapplications and to meet critical requirements for the mass market—highreliability, high security, low power, small form factor and low cost.The technology disclosed meets this goal. The technology involves amedical signal processor (MSP) closely supervising all aspects offunctionality of its peripheral wireless patches to help achieve theobjectives. The patches are simple while the medical signal processor(MSP) has all the smarts to work with patches. It results in asymmetricprocessing load on MSP and patches—patches are simple and reconfigurableand MSP has the complexity to take the processing burden from them forwireless communication link, and processing load to supervise patches.Both the MSP and the patches have various resources to build completeself contained systems to determine a health state of a person fromsensor physiological data and to display and/or send data to anotherdevice for further processing.

One aspect of the invention is a method for monitoring a physiologicalcondition using two or more ASIC chips and a host device wherein thechips are designed to work together to measure physiological signals,wherein (a) one of the chips is a patch-ASIC chip incorporated into aphysiological monitoring patch comprising a sensor interface formeasuring physiological signals, a processor for processing the signalsinto sensor data, memory for storing data relating to the signals, aradio for transmitting sensor data, and power management circuits forcontrolling power on the chip; and (b) one of the chips is a base-ASICchip comprising a processor for processing sensor data, memory forstoring data relating to the signals, a radio for transmittinginstructions to the patch-ASIC chip, power management circuits forcontrolling power on the chip, and a host interface allowing thebase-ASIC chip to communicate with the host device; wherein thebase-ASIC chip controls a function of the physiological signalmonitoring patch.

Some embodiments of the method are methods to manage a patient'sdisease. They types of diseases that can be managed include arrhythmia,heart failure, coronary heart disease, diabetes, sleep apnea, seizures,asthma, COPD, pregnancy complications, and wound state.

Some embodiments of the method are methods to manage a condition relatedto the wellness and fitness of a person. The types of conditions thatcan be managed include weight loss, obesity, heart rate, cardiacperformance, dehydration rate, blood glucose, physical activity orcalorie intake, or combinations thereof.

One aspect of the invention is method for unsupervised placement of aphysiological patch that involves: (a) placing the patch that canreceive wireless signals from a base device wherein the patch comprisesa visual marker to help the user orient the patch on the patient's body;(b) initializing the patch with a base device by automatic verificationof proper placement of the patch; and (c) indicating the proper orimproper placement of the patch to the user with an audio or visualindication. The indication of proper placement can be provided by anaudio or visual signal either on the patch, on the base device, on thehost device, or on another device.

One aspect of the invention is a business method relating to theproduction and use of sets of ASIC chips that are designed to worktogether to measure physiological signals. The business method involvesmanufacturing both a patch-ASIC chip and a base-ASIC chip that aredesigned to work together to wirelessly communicate physiological data,wherein each chip each comprises a processor, memory storage, a radio,and circuits for power management. In some embodiments, the chips aredesigned to be used with a plurality sensor types. The method comprisesselling and/or licensing the patch-ASIC chip and base-ASIC chip tomultiple customers for incorporation into physiological sensing systems.This business model contemplates the value of selling a chip set thatcan be used in multiple types of physiological monitoring applications.The fact that the chips are designed to work together to conserve energyand to maximize communication provides value to the system manufacturerand the end user. The fact that the chips can be used in multipleapplications allows the volume of ASIC chip manufacturing to be highenough to provide to provide the economy of scale to make the ASICdevices cost effective. The plurality of sensor types include sensorsthat measure ECG, EEG, EMG, SpO₂, tissue impedance, heart rate, andaccelerometer signals.

The business methods can be applied to sensor systems for monitoring apatient disease or for monitoring health and fitness conditions asdescribed above.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An asymmetric system comprising: two or more ASICchips wherein the chips are designed to work together to measurephysiological signals, comprising: (a) a patch-ASIC chip adapted forincorporation into a physiological signal monitoring patch comprising asensor interface, a processor coupled to the sensor interface, a memoryelement coupled to the processor, a radio coupled to the memory elementthat transmits data to a base-ASIC chip, and power management circuitsthat coordinate power usage on the chip; and (b) the base-ASIC chip,comprising a processor that processes sensor data, a memory elementcoupled to the processor, a radio coupled to the memory element thatcommunicates instructions to the patch-ASIC chip, power managementcircuits for coordinating power usage on the chip, and a host interfacethrough which the base-ASIC chip communicates with a host device;wherein the base-ASIC chip has more processing resources than thepatch-ASIC chip.
 2. The system of claim 1 wherein the base-ASIC has ahigher silicon area than the patch-ASIC chip.
 3. The system of claim 2wherein the ratio of silicon area of the base-ASIC chip to thepatch-ASIC chip is at least about 2:1.
 4. The system of claim 2 whereinthe ratio of silicon area of the base-ASIC chip to the patch-ASIC chipis at least about 4:1.
 5. The system of claim 1 wherein the patch-ASICchip comprises low-complexity transmitters and low complexity receivers,and the base-ASIC chip comprises high-complexity transmitters and highcomplexity receivers.
 6. The system of claim 5 wherein the patch-ASICchip comprises a UWB transmitter and a narrowband receiver, and thebase-ASIC chip comprises a narrow band transmitter and a UWB receiver.7. The system of claim 1 wherein the patch-ASIC chip comprises a turboencoder, and the base-ASIC chip comprises a turbo-decoder.
 8. The systemof claim 1 wherein the patch-ASIC chip communicates through a singleantenna, and the base-ASIC chip communicates through multiple antennas.9. The system of claim 8 wherein the base-ASIC chip further comprisessmart antenna processing.
 10. The system of claim 1 wherein thebase-ASIC chip, comprises processors for analyzing the radioenvironment.
 11. The system of claim 1 wherein the system comprises abase-ASIC chip and multiple patch-ASIC chips.
 12. A method comprising:monitoring a physiological condition using two or more ASIC chips and ahost device wherein the chips are designed to work together to measurephysiological signals comprising: (a) receiving signals from a sensor ata patch-ASIC chip that is incorporated into a physiological signalmonitoring patch, the patch-ASIC chip comprising a sensor interfacecoupled to the sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement; (b) transmitting data signals from the radio on the patch-ASICchip through an antenna incorporated into the patch; (c) receiving thedata signals at a base-ASIC chip comprising an antenna that sends thesignals to a processor that processes data signals, a memory elementcoupled to the processor, a radio coupled to the memory element, and ahost interface through which the base-ASIC chip communicates with a hostdevice; and (d) transmitting instructions wirelessly from the base-ASICchip to the patch-ASIC chip; wherein the base-ASIC chip consumes morepower than the patch-ASIC chip.
 13. The method of claim 12 wherein theratio of power consumed by the base-ASIC chip to the power consumed bythe patch-ASIC chip measured during continual data transmission is 2:1.14. The method of claim 12 wherein the ratio of power consumed by thebase-ASIC chip to the power consumed by the patch-ASIC chip measuredduring continual data transmission is 4:1.
 15. A system comprising twoor more ASIC chips wherein the chips are designed to work together tomeasure physiological signals, comprising: (a) a patch-ASIC chip adaptedfor incorporation into a physiological signal monitoring patchcomprising a sensor interface, a processor coupled to the sensorinterface, a memory element coupled to the processor, a radio coupled tothe memory element that transmits data to a base-ASIC chip, and powermanagement circuits that coordinate power on the chip; and (b) thebase-ASIC chip comprising a processor that processes sensor data, amemory element coupled to the processor, a radio coupled to the memoryelement that that transmits instructions to the patch-ASIC chip, powermanagement circuits for coordinating power on the chip, and a hostinterface through which the base-ASIC chip communicates with a hostdevice.
 16. The system of claim 15 wherein the base-ASIC chip isincorporated into a μ-Base and the patch-ASIC chip is incorporated intoa μ-Patch, wherein each of the μ-Base and the μ-Patch comprise a printedcircuit board and an antenna attached to the printed circuit board fortransmitting radio signals.
 17. The system of claim 15 wherein thebase-ASIC chip acts as a master device to coordinate a function of theμ-Patch.
 18. The system of claim 17 wherein a function coordinated bythe base-ASIC chip is initialization and link set up, power management,data packet routing, type of transmission radio, radio transmit-power,radio receive-sensitivity, patch operational integrity, audio tonegeneration, display activation, or a combination thereof.
 19. The systemof claim 17 wherein the base-ASIC chip can coordinate the bias of the RFcircuitry on the patch-ASIC chip to coordinate energy usage on thepatch.
 20. The system of claim 15 wherein the base-ASIC chip isincorporated into the host device; wherein the host device comprises astationary, portable, or mobile device or a stationary, portable, ormobile medical instrument.
 21. The system of claim 15 wherein thebase-ASIC chip is incorporated into an adapter which plugs into the hostdevice; wherein the host device comprises a stationary, portable ormobile device or a stationary, portable, or mobile medical instrument.22. The system of claim 21 wherein the adapter comprising the base-ASICchip plugs into a medical instrument through a serial interfaceconnection.
 23. The system of claim 21 wherein the adapter providesphysiological information from wireless sensors to a stationary,portable, or mobile medical instrument that was designed for receivingphysiological information from wired sensors, wherein the adapter allowsthe medical instrument to receive substantially equivalent informationfrom the wireless sensors.
 24. The system of claim 21 wherein theadapter allows a medical instrument which is designed to be connected tosensors by wires to be compatible with sensors that transmit wirelessly.25. The system of claim 16 wherein the base-ASIC chip is incorporatedinto a cell phone.
 26. The system of claim 15 wherein the patch-ASICchip and the base-ASIC chip are each part of an ASIC superset chip,wherein the functionality of both the patch-ASIC chip and the base-ASICchip are contained on the ASIC superset chip, and wherein un-usedportions of the superset chip are turned off on the patch-ASIC chip orthe base-ASIC chip.
 27. The system of claim 15 wherein the two or moreASIC chips can send and/or receive both ultrawide band (UWB) radio andnarrowband radio signals.
 28. The system of claim 17 wherein thebase-ASIC chip can switch the transmission mode of the patch-ASIC chipbetween UWB and narrowband radio.
 29. The system of claim 16 wherein thepatch-ASIC chip comprises an encoding scheme for encoding datatransmission and the base-ASIC chip comprises a decoding scheme fordecoding data transmission from the μ-Patch.
 30. The system of claim 15wherein the system provides security by an encryption scheme usingshared keys, wherein the device comprising the base-ASIC chip wirelesslyexchanges the shared keys with the patch.
 31. The system of claim 16wherein the ASIC chips can avoid or minimize interference bypseudo-random hopping of carrier frequencies, or by data modulation withpseudo-random code sequences.
 32. The system of claim 16 wherein thesystem provides reliability by forward-error correction,packet-retransmission by automatic repeat request (ARQ), and/or smartantenna techniques.
 33. The system of claim 16 wherein the μ-Patchcomprises one antenna and the μ-Base comprises 2 or more antennas. 34.The system of claim 16 wherein the μ-Patch performs compression of theradio signal and the μ-Base performs decompression of the radio signal.35. The system of claim 16 wherein the μ-Base further comprise a poweramplifier external to the base-ASIC chip for amplifying sensor datasignal.
 36. The system of claim 16 wherein the μ-Base can transmit at 5times higher power than the μ-Patch.
 37. The system of claim 15comprising one base-ASIC chip and multiple patch-ASIC chips.
 38. Thesystem of claim 16 wherein the μ-Patch uses on average less than about 6mW of power.
 39. The system of claim 38, wherein the patch-ASIC chip cantransmit more than about 1 KB of data per day to the base-ASIC chip. 40.The system of claim 38, wherein the patch-ASIC chip can transmit morethan about 1 KB of data per day at a range of up to 30 m to thebase-ASIC chip.
 41. A system comprising three or more ASIC chips whereinthe chips are designed to work together to measure physiologicalsignals, comprising: (a) a patch-ASIC chip adapted for incorporationinto a physiological signal monitoring patch comprising a sensorinterface, a processor coupled to the sensor interface, a memory elementcoupled to the processor, a radio coupled to the memory element thattransmits sensor data to a base-ASIC chip and/or a gate-ASIC chip, andpower management circuits that coordinate power on the chip; (b) thegate-ASIC chip comprising a processor that processes sensor data, amemory element coupled to the processor, a radio coupled to theprocessor that communicates with the patch-ASIC chip and the base-ASICchip, and power management circuits that coordinate power on the chip;and (c) the base-ASIC chip comprising a processor that processes sensordata, a memory element coupled to the processor, a radio coupled to thememory element that that transmits instructions to the patch-ASIC chipand/or the gate-ASIC chip, power management circuits that coordinatepower on the chip, and a host interface through which the base-ASIC chipcommunicates with a host device.
 42. The system of claim 41 wherein thebase-ASIC chip is incorporated into a μ-Base, the patch-ASIC chip isincorporated into a μ-Patch, and the gate-ASIC chip is incorporated intoa μ-Gate; wherein each of the μ-Base, μ-Patch, and μ-Gate comprise aprinted circuit board and an antenna attached to the printed circuitboard for transmitting radio signals.
 43. The system of claim 41 whereinthe gate-ASIC chip further comprises a sensor interface for receivingsignals from sensors, wherein the μ-Gate is incorporated into a patch.44. The system of claim 41 wherein the μ-Patch only transmits UWB, andthe μ-Gate has both a UWB and a narrowband radio.
 45. The system ofclaim 41 wherein the base-ASIC chip acts as a master device tocoordinate a function of the μ-Patch or the μ-Gate or both the μ-Patchand the μ-Gate.
 46. The system of claim 42 wherein the base-ASIC chipcan switch the transmission mode of the μ-Patch and/or the μ-Gatebetween UWB and narrowband radio.
 47. The system of claim 41 wherein thebase-ASIC chip is incorporated into the host device; wherein the hostdevice comprises a stationary, portable, or mobile device or astationary, portable, or mobile medical instrument.
 48. The system ofclaim 41 wherein the base-ASIC chip is incorporated into an adapterwhich plugs into the host device; wherein the host device comprises astationary, portable or mobile device or a stationary, portable, ormobile medical instrument.
 49. The system of claim 41, wherein thegate-ASIC chip communicates wirelessly with both the patch-ASIC chip andthe base-ASIC chip.
 50. The system of claim 44 wherein the patch-ASICchip and the gate-ASIC chip are each members of an ASIC superset; andwherein the unused portions on the patch-ASIC chip and/or the base-ASICare turned off.
 51. The system of claim 41 wherein the patch-ASIC chip,the gate-ASIC chip and the base-ASIC chip are each part of an ASICsuperset chip, wherein the functionality of two or more of thepatch-ASIC chip, the gate-ASIC chip and the base-ASIC chip are containedon the ASIC superset chip, and wherein un-used portions of the supersetchip are turned off on the patch-ASIC chip, the gate-ASIC chip, or thebase-ASIC chip.
 52. The system of claim 48 wherein the adaptercomprising the base-ASIC chip plugs into a medical instrument through aserial interface connection.
 53. The system of claim 48 wherein theadapter provides physiological information from wireless sensors to astationary, portable, or mobile medical instrument that was designed forreceiving physiological information from wired sensors, wherein theadapter allows the medical instrument to receive substantiallyequivalent information from the wireless sensors.
 54. The system ofclaim 48 wherein the adapter allows a medical instrument which isdesigned to be connected to sensors by wires to be compatible withsensors that transmit wirelessly.
 55. A patch for measuring aphysiological state comprising a battery and an antenna each coupled toan integrated circuit comprising a sensor interface that receivesphysiological signals from a sensor, a processor coupled to the sensorinterface, a memory element coupled to the processor, a radio coupled tothe memory element, and power management circuits that coordinate powerdissipation on the chip; wherein the area of the patch multiplied by thethickness of the patch is less than about 30 cm³; and wherein the patchcan wirelessly transmit physiological data for at least about 2 dayswhile monitoring a physiological signal from the patient withoutchanging or recharging the battery.
 56. The patch of claim 55 whereinthe monitoring of the physiological signal is sampled substantiallycontinuously.
 57. The patch of claim 55 wherein the signal is sampledsubstantially continuously at greater than 200 Hz.
 58. The patch ofclaim 55, wherein the patch can wirelessly transmit physiological datafor at least about 4 days.
 59. The patch of claim 55, wherein thebattery provides a charge of about 250 mA-hours or less.
 60. The patchof claim 55, wherein the patch buffers data obtained from monitoring aphysiological signal then transmits the data in bursts.
 61. The patch ofclaim 55, wherein the patch uses on average less than about 10 mW ofpower.
 62. The patch of claim 55, wherein the patch can transmit morethan about 1 KB of sensor data per day at a range of up to 30 m.
 63. Thepatch of claim 55, wherein the power management circuits coordinate dutycycle with clock-gating with protocol-level sleep modes.
 64. The patchof claim 55, wherein the patch can measure signals in continuous,episodic, and/or periodic modes.
 65. The patch of claim 55 wherein thepatch also comprises a sensor.
 66. The patch of claim 65 wherein thesensor comprises electrodes and senses electrical signals.
 67. The patchof claim 66 wherein the sensor measures EEG, EMG, or ECG signals orcombinations thereof.
 68. The patch of claim 55 wherein the ASIC chipcan send and/or receive both ultra-wideband (UWB) and narrowband radiosignals.
 69. The patch of claim 55 wherein the patch comprisesdisposable and reusable parts.
 70. The patch of claim 69 wherein asensor and/or the battery are disposable, and substantially all of theelectronics are reusable.
 71. The patch of claim 55 wherein the patch isdisposable.
 72. The patch of claim 55 wherein the sensor is separatefrom the patch and electrically connected to the patch.
 73. The patch ofclaim 55 wherein the sensor measures ECG, EEG, EMG, SpO₂, tissueimpedance, heart rate, accelerometer, blood glucose, PT-INR, respirationrate and airflow volume, body tissue state, bone state, pressure,physical movement, body fluid density, patient physical location, oraudible body sounds, or a combination thereof.
 74. The patch of claim 55wherein the patch can generate stimulus signals that are detected bysensors connected to or incorporated into the patch or connected to orincorporated into another patch.
 75. The patch of claim 74 wherein thestimulus signals are electrical, ultrasound, or radio wave signals. 76.The patch of claim 75 wherein the electrical signals are used to measureskin or body impedance.
 77. The patch of claim 55 wherein the patchcomprises an alert which is an audio signal generator or a visualdisplay.
 78. The patch of claim 55 wherein the battery can be re-chargedvia electromagnetic induction.
 79. A patch for measuring a physiologicalstate comprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the patch is a cardiac patch that can measure allof ECG, SpO₂, tissue impedance, accelerometer, and PT-INR signals.
 80. Apatch for measuring a physiological state comprising a battery and anantenna each coupled to an integrated circuit comprising a sensorinterface that receives physiological signals from a sensor, a processorcoupled to the sensor interface, a memory element coupled to theprocessor, a radio coupled to the memory element, and power managementcircuits that coordinate power dissipation on the chip; wherein thepatch is a neurological patch for measuring sleep apnea that can measureall of EEG, EMG, SpO₂, heart rate, respiration rate and airflow volume,and pressure signals.
 81. A patch for measuring a physiological statecomprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the patch is an endocrinological patch formeasuring diabetes or wounds that can measure all of ECG, blood glucose,and UWB radar signals.
 82. A patch for measuring a physiological statecomprising a battery and an antenna each coupled to an integratedcircuit comprising a sensor interface that receives physiologicalsignals from a sensor, a processor coupled to the sensor interface, amemory element coupled to the processor, a radio coupled to the memoryelement, and power management circuits that coordinate power dissipationon the chip; wherein the patch is fitness and wellness patch that canmeasure all of ECG, heart rate, accelerometer, and pressure signals. 83.A method comprising monitoring a physiological condition using two ormore ASIC chips and a host device wherein the chips are designed to worktogether to measure physiological signals comprising: (a) receivingsignals from a sensor at a patch-ASIC chip that is incorporated into aphysiological signal monitoring patch, the patch-ASIC chip comprising asensor interface coupled to the sensor, a processor coupled to thesensor interface, a memory element coupled to the processor, a radiocoupled to the memory element; (b) managing the power dissipation on thepatch-ASIC chip with power management circuits on the patch-ASIC chip;(c) transmitting data signals from the radio on the patch-ASIC chipthrough an antenna incorporated into the patch; (d) receiving the datasignals at a base-ASIC chip comprising a processor that processes datasignals, a memory element coupled to the processor, a radio coupled tothe memory element, power management circuits that coordinate powerdissipation on the base-ASIC chip, and a host interface through whichthe base-ASIC chip communicates with a host device; and (e) sendinginstructions wirelessly from the base-ASIC chip to the patch-ASIC chipsuch that the base-ASIC chip coordinates a function of the physiologicalsignal monitoring patch.
 84. The method of claim 83 wherein a functioncoordinated by the base-ASIC chip is initialization and link set up,power management, data packet routing, type of transmission radio, radiotransmit-power, radio receive-sensitivity, patch operational integrity,audio signal generation, display activation, or a combination thereof.85. The method of claim 83 wherein the ASIC chips function on apacket-data protocol and the base-ASIC chip coordinates data packetrouting.
 86. The method of claim 83 wherein the base-ASIC chip keepstrack of the quality of the wireless links between ASIC chips and sendscommands to the patch-ASIC chip and/or gate-ASIC chips to instruct thechips to switch between UWB and narrowband radio or to raise or lowertransmit power in order to lower power consumption or to enhancecommunication quality.
 87. The method of claim 83 wherein the patch-ASICchip is authenticated by bringing the physiological monitoring patch inproximity of the device comprising the base-ASIC chip.
 88. The system ofclaim 87 wherein the authentication is provided by an encryption schemeusing shared keys, wherein the device comprising the base-ASIC chipwirelessly exchanges the shared keys with the patch.
 89. The system ofclaim 88 wherein the encryption scheme is an Advanced EncryptionStandard (AES) scheme.
 90. The method of claim 83 wherein a user isalerted with an audio and/or a visual signal.
 91. The method of claim 90wherein the audio and/or visual signal is generated on the patch. 92.The method of claim 90 wherein the audio and/or visual signal isgenerated on a device to which the base-ASIC chip is connected.
 93. Themethod of claim 83 wherein the method is used to manage a patientdisease.
 94. The method of claim 93 wherein the patient disease isarrhythmia, heart failure, coronary heart disease, diabetes, sleepapnea, seizures, asthma, COPD, pregnancy complications, and wound stateor combinations thereof.
 95. The method of claim 83 wherein the methodis used to manage a condition related to the state of wellness andfitness of a person.
 96. The method of claim 95 wherein the conditionbeing managed is weight loss, obesity, heart rate, cardiac performance,dehydration rate, blood glucose, physical activity or calorie intake, orcombinations thereof.
 97. A method comprising monitoring a physiologicalcondition using three or more ASIC chips wherein the chips are designedto work together to measure physiological signals, comprising: (a)receiving physiological signals from sensors at a patch-ASIC chipincorporated into a physiological signal monitoring patch, thepatch-ASIC chip comprising a sensor interface, a processor coupled tothe sensor interface, a memory element coupled to the processor, a radiocoupled to the memory element; (b) managing power dissipation on thepatch-ASIC chip with power management circuits on the patch-ASIC chip;(c) transmitting data to a base-ASIC and/or a gate-ASIC chip through anantenna in the patch; (d) receiving the data sent from the patch-ASICchip at the gate-ASIC chip, the gate-ASIC chip comprising a processorthat processes sensor data, a memory element coupled to the processor, aradio coupled to the processor that communicates with the patch-ASICchip and the base-ASIC chip, and power management circuits forcoordinating power dissipation on the gate-ASIC chip; (e) coordinating afunction on the patch-ASIC chip and/or gate-ASIC chip by sendinginstructions from a base-ASIC chip to the patch-ASIC chip and/or thegate-ASIC chip, wherein the base-ASIC chip comprises a processor thatprocesses sensor data, a memory element coupled to the processor, aradio coupled to the memory element, power management circuits forcoordinating power dissipation on the base-ASIC chip; and (f) sendingdata from the base-ASIC chip to a host device through a host interface.98. The method of claim 97 wherein the base-ASIC chip is incorporatedinto a μ-Base, the patch-ASIC chip is incorporated into a μ-Patch, andthe gate-ASIC chip is incorporated into a μ-Gate; wherein each of theμ-Base, μ-Patch, and μ-Gate comprise a printed circuit board and anantenna attached to the printed circuit board for transmitting andreceiving radio signals.
 99. The method of claim 97 wherein thegate-ASIC chip further comprises a sensor interface for receivingsignals from sensors, wherein the gate-ASIC is incorporated into apatch.
 100. The method of claim 98 wherein the μ-Patch only transmitsUWB, and the μ-Gate comprises both UWB and narrowband radios.
 101. Themethod of claim 98 wherein the base-ASIC chip acts as a master device tocoordinate a function of the μ-Patch or the μ-Gate or both the μ-Patchand the μ-Gate.
 102. The method of claim 98 wherein the base-ASIC chipkeeps track of the quality of the wireless links between ASIC chips andsends commands to the patch-ASIC chip and/or gate-ASIC chips to instructthe chips to switch between UWB and narrowband radio or to raise orlower transmit power in order to lower power consumption or to enhancecommunication quality.
 103. The method of claim 98 wherein the base-ASICchip is incorporated into the host device; wherein the host devicecomprises a stationary, portable, or mobile device or a stationary,portable, or mobile medical instrument.
 104. The method of claim 98wherein the base-ASIC chip is incorporated into an adapter which plugsinto the host device; wherein the host device comprises a stationary,portable or mobile device or a stationary, portable, or mobile medicalinstrument.
 105. The method of claim 97, wherein the gate-ASIC chipcommunicates wirelessly with both the patch-ASIC chip and the base-ASICchip.
 106. The method of claim 100 wherein the patch-ASIC chip and thegate-ASIC chip are each members of an ASIC superset; and wherein anunused function on the patch-ASIC chip is turned off.
 107. The method ofclaim 97 wherein the patch-ASIC chip, the gate-ASIC chip and thebase-ASIC chip are each part of an ASIC superset chip, wherein thefunctionality of two or more of the patch-ASIC chip, the gate-ASIC chipand the base-ASIC chip are contained on the ASIC superset chip, andwherein un-used portions of the superset chip are turned off on thepatch-ASIC chip, the gate-ASIC chip, or the base-ASIC chip.
 108. Themethod of claim 104 wherein the adapter comprising the base-ASIC chipplugs into a medical instrument through a serial interface connection.109. The method of claim 104 wherein the adapter provides physiologicalinformation from wireless sensors to a stationary, portable, or mobilemedical instrument that was designed for receiving physiologicalinformation from wired sensors, wherein the adapter allows the medicalinstrument to receive substantially equivalent information from thewireless sensors.
 110. The method of claim 104 wherein the adapterallows a medical instrument which is designed to be connected to sensorsby wires to be compatible with sensors that transmit wirelessly.
 111. Amethod comprising receiving physiological signals from sensors at apatch wherein the patch comprises a battery and an antenna each coupledto an integrated circuit comprising a sensor interface that receives thephysiological signals from the sensor, a processor coupled to the sensorinterface that receives signals from the sensor interface and processesthe signals, a memory element coupled to the processor that receives andstores signals, and a radio coupled to the memory element that sendssignals received from the memory element to an antenna, wherein powermanagement circuits coordinate power dissipation on the chip; whereinthe area of the patch multiplied by the thickness of the patch is lessthan about 30 cm³; and wherein the patch can wirelessly transmitphysiological data for at least about 2 days while monitoring aphysiological signal from the patient without changing or recharging thebattery.
 112. The method of claim 111 wherein the monitoring of thephysiological signal is sampled substantially continuously.
 113. Themethod of claim 111 wherein the signal is sampled substantiallycontinuously at greater than 200 Hz.
 114. The method of claim 111,wherein the method can wirelessly transmit physiological data for atleast about 4 days.
 115. The method of claim 111, wherein the batteryprovides a charge of about 250 mA-hours or less.
 116. The method ofclaim 111, wherein the patch buffers data obtained from monitoring aphysiological signal then transmits the data in bursts.
 117. The methodof claim 111, wherein the patch uses on average less than about 10 mW ofpower.
 118. The method of claim 111, wherein the patch can transmit morethan about 1 KB of sensor data per day at a range of up to 30 m. 119.The method of claim 111, wherein the power management circuitscoordinate duty cycle with clock-gating with protocol-level sleep modes.120. The method of claim 111, wherein the patch can measure signals incontinuous, episodic, and/or periodic modes.
 121. The method of claim111 wherein the patch also comprises the sensor.
 122. The method ofclaim 121 wherein the sensor comprises electrodes and senses electricalsignals.
 123. The method of claim 122 wherein the sensor measures EEG,EMG and ECG signals or combinations thereof.
 124. The method of claim111 wherein the ASIC chip can send and/or receive both ultra-wideband(UWB) and narrowband radio signals.
 125. The method of claim 111 whereinthe patch comprises disposable and reusable parts.
 126. The method ofclaim 125 wherein a sensor and/or the battery are disposable, andsubstantially all of the electronics are reusable.
 127. The method ofclaim 111 wherein the patch is disposable.
 128. The method of claim 111wherein the sensor is separate from the patch and electrically connectedto the patch.
 129. The method of claim 111 wherein the sensor measuresECG, EEG, EMG, SpO₂, tissue impedance, heart rate, accelerometer, bloodglucose, PT-INR, respiration rate and airflow volume, body state, bonestate, pressure, physical movement, body fluid density, patient physicallocation, or audible body sounds, or a combination thereof.
 130. Themethod of claim 111 wherein the method can generate stimulus signalsthat are detected by sensors connected to or incorporated into the patchor connected to or incorporated into another patch.
 131. The method ofclaim 130 wherein the stimulus signals are electrical, ultrasound, orradio wave signals.
 132. The method of claim 131 wherein the electricalsignals are used to measure skin or body impedance.
 133. The method ofclaim 111 wherein the patch comprises an alert which is an audio signalgenerator or a visual display.
 134. The method of claim 111 wherein thebattery can be re-charged magnetically.
 135. The method of claim 111wherein the patch is a cardiac patch that can measure all of ECG, SpO₂,tissue impedance, accelerometer, and PT-INR signals.
 136. The method ofclaim 111 wherein the patch is a neurological patch for measuring sleepapnea that can measure all of EEG, EMG, SpO₂, heart rate, respirationrate and airflow volume, and pressure signals.
 137. The method of claim111 wherein the patch is an endocrinological patch for measuringdiabetes or wounds that can measure all of ECG, blood glucose, and UWBradar signals.
 138. The method of claim 111 wherein the patch is fitnessand wellness patch that can measure all of ECG, heart rate,accelerometer, and pressure signals.
 139. A method for unsupervisedplacement of a physiological patch comprising: (a) placing the patchthat can receive wireless signals from a base device, wherein the patchcomprises a visual marker to help the user orient the patch on thepatient's body; (b) initializing the patch with a base device byautomatic verification of proper placement of the patch; and (c)indicating the proper or improper placement of the patch to the userwith an audio or visual indication.
 140. A business method comprising:(a) manufacturing both a patch-ASIC chip and a base-ASIC chip designedto work together to wirelessly communicate physiological data, whereineach chip each comprises a processor, memory storage, a wireless radio,and circuits for power management, wherein the chips are designed to beused with a plurality sensor types; and (b) selling and/or licensing thepatch-ASIC chip and base-ASIC chip to multiple customers forincorporation into physiological sensing systems.
 141. The businessmethod of claim 140 wherein the plurality of sensor types includesensors that measure all of ECG, EEG, EMG, SpO₂, tissue impedance, heartrate, and accelerometer signals.
 142. The business method of claim 140further comprising a gate-ASIC chip designed to work together with thepatch-ASIC chip and the base-ASIC chip, to wirelessly communicatephysiological data, wherein each chip each comprises a processor, memorystorage, a wireless radio, and circuits for power management, whereinthe chips are designed to be used with a plurality sensor types.